Trigeminal NeuropathyPhase 2NCT05142228
Erenumab-aooe for the Management of Trigeminal Neuropathic Pain.
A Phase 2 study testing Erenumab-Aooe in people with Trigeminal Neuropathy, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This study is a single center, placebo-controlled, double blind, randomized, phase II pilot to evaluate the efficacy of erenumab-aooe in the management of trigeminal neuropathic pain comparing erenumab-aooe vs Placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trigeminal Neuropathy
- What is being tested?
- Erenumab-Aooe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2022to 27 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provide signed and dated informed consent form
- Is between 18 and 65 years of age (inclusive; male or female and any race or ethnicity)
- Trigeminal neuropathic pain symptoms for a minimum of 3 months prior to randomization visit, localized in any trigeminal distribution (intraoral or extraoral).
- Meets diagnostic criteria for Trigeminal neuropathic pain with diagnosis based on the International classification of headache disorders ICHD-3 and International classification of Orofacial Pains ICOP.
- Diagnosed with idiopathic trigeminal neuralgia with concomitant continuous pain per ICDH-3.
Show all 22Show fewer
- Diagnosed with Painful posttraumatic trigeminal neuropathy or idiopathic painful trigeminal neuropathy per ICOP. May include:
- Subjects with a history of persistent pain of idiopathic origin or after dental extractions, mandibular fracture, surgical procedure, implant procedure and root canal therapy.
- Participants must have a minimum mean of average daily pain intensity score of 4/10 in where 0= no pain and 10= maximum pain imaginable on a numerical rating scale (0-10), during the 4 weeks/28 days baseline period prior randomization.
- If taking a prescription medication daily for the management of pain (taken for at least 30 days before baseline), agrees to continue the daily use of the medication throughout the study at the same dosage.
- If taking prescription medication, opioid medication or OTC medications as needed or episodically for the management of pain agrees to discontinue its use prior to the Screening and Baseline Visit.
- If taking OTC pain medications daily agrees to continue its daily use at the same dosage throughout the study.
- If a participant is taking an over-the-counter medication daily for management of other type of pain or for prophylaxis of myocardial infarction or stroke, the participant will be encouraged to continue the same usage of that medication throughout the study.
- If subjects diagnosed with migraine, are allowed only if episodic, with attacks of duration up to 5 days/month and only using triptans or NSAIDs as an abortive medication.
- Agrees to not start any new prescription medication for the management of trigeminal neuropathic pain or other type of pain throughout the study.
- Agrees to not modify their prescription regimen for current trigeminal neuropathic pain or other types of pain throughout the study
- Agrees not to receive any injection therapy for the management of neuropathic pain or migraine (e.g. nerve blocks, SPG blocks, steroid injections, Botox) during the course of the study
- Agrees not to use any neuromodulatory device for the management of neuropathic pain or migraine during the course of the study
- Agrees not to undergo any surgical procedure for the management of neuropathic pain during the course of the study
- Agrees to not use cognitive behavioral therapy (CBT), biofeedback or acupuncture for the management of pain during the course of the study.
- Females of childbearing potential agree to use one of the following methods of contraception throughout the study: licensed hormonal method, intrauterine device, female or male condoms with contraceptive foam, abstinence, bilateral tubal ligation/occlusion, or vasectomy in partner (if postmenopausal, must not have menstruated for at least 12 consecutive months)
- Willing and able to understand and comply with all study procedures and be available for the duration of the study.
Who cannot join
- Participants with a history of congestive heart failure or uncontrolled diabetes.
- Participants with serious hepatic, respiratory, hematologic or immunologic illnesses, an unstable cardiovascular disease, or any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or Erenumab or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the participant inappropriate for entry into this trial.
- Participants with high blood pressure, uncontrolled high blood pressure, malignant disease, chronic constipation, any malabsorption disorders such as IBSc or any other severe acute or chronic medical or psychiatric condition (major depression, schizophrenia, dementia) or laboratory finding that may increase the risk associated with trial participation with Erenumab, that in the judgement of the investigators would interfere with study assessments and/or would make the participant inappropriate for entry into this trial.
- Participants with active malignancy of any type or a history a malignancy (with exception of participants with malignancy surgically removed with no evidence of recurrence within 5 years before enrollment.
- Participants with evidence or a history of drug or alcohol abuse within the past 12 months or has been diagnosed with a substance abuse disorder.
- Participants with dental pain (determined pain of odontogenic/periodontal origin).
Show all 21Show fewer
- Participants with significant neurological disorders.
- Patients with chronic migraine with and w/o aura following the ICHD-3 criteria treated or not treated with medication
- Without excluding headache attributed to TMD
- Participants currently taking or have previously taken Erenumab or other CGRP monoclonal antibody (mAmb) or currently taking a CGRP-Receptor antagonist (gepants) for migraine prevention.
- Patients with hypersensitivity to Erenumab
- Participants with trigeminal neuropathic pain taken medications for the management of trigeminal neuropathic pain in where daily dosage has been modified within three weeks before baseline.
- Neuroimaging showing the presence of neurovascular compression or AV malformation.
- Neuroimaging showing the presence of intracranial pathology (i.e. multiple sclerosis, tumor).
- Presence of extracranial pathology in the area of pain (tumor, lesion).
- Has been treated with another investigational drug or treatment within 30 days prior to the Screening and Baseline Visit
- Has commenced a new daily prescription medication for the management of pain within 30 days prior to the Screening and Baseline Visit
- Currently taking opioid medication whether episodically or daily, within 30 days prior to the Screening and Baseline Visit.
- Patients sensitive to Latex
- If planning to become pregnant, pregnant or breastfeeding.
- Anything that, in the opinion of the investigator, would place the participant at increased risk or impede the participant's full compliance with or completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, School of Dentistry, Brotman Facial Pain Clinic
Baltimore, Maryland, 21201
About this study
Official title: Erenumab as a Therapeutic Approach for the Management of Trigeminal Neuropathic Pain (TNP)
This study is a single center, placebo-controlled, double blind, randomized, phase II pilot to evaluate the efficacy of erenumab-aooe in the management of trigeminal neuropathic pain comparing erenumab-aooe vs Placebo.
A total of 40 patients (20 each arm) aged 18-65 years old of either sex, and any race or ethnicity, presenting trigeminal neuropathic pain will be randomly assigned in a 1:1 parallel, double-blind clinical trial, to receive either Erenumab or placebo. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks. Changes in pain intensity and other pain related outcomes of trigeminal neuropathic pain will be assessed. Blood samples will be collected, and participants will need to keep a daily symptom diary and answer some other questionnaires.
Read the detailed description
TNP are a considerable burden and affects significantly the quality of life of the sufferer. There are medications for their management but while they may work for some patients, may not work for the others; in addition, side effects may be present for some patients with the need to decrease dosage to not optimal levels. Furthermore, the indications of these drugs are for other neuropathic pain disorders and currently there is no medication specifically indicated for the management of TNP based on its molecular pathophysiology.
The calcitonin gene-related peptide (CGRP) is a key neuropeptide involved in migraine pathophysiology. There is evidence showing that CGRP has a role in other disorders mediated by the trigeminal system in addition to migraine; CGRP has shown to have a role in orofacial pain such as in TMD and in trigeminal neuropathic pain. Erenumab-aooe is the first antibody therapeutic targeting the CGRP receptor with FDA approval for migraine prevention that is well tolerated and with a good safety profile. Therefore, the scientific premise for this study is that inhibiting the CGRP pathway in trigeminal neuropathic pain will decrease pain and pain related outcomes in a safe and well tolerated manner for this patient population.
Potential participants will be pre-screened at the Brotman Facial Pain clinic, at the Oral and Maxillofacial Surgery Clinic both at the University of Maryland, School of Dentistry, at the Pain Medicine Clinic at the University of Maryland, School of Medicine or by telephone; those willing to participate will be scheduled for a screening and baseline visit (Visit 0). During this visit, potential participants will be evaluated for eligibility for trigeminal neuropathic pain (subjects with diagnosis based on the International classification of headache disorders ICHD-3 and International classification of Orofacial Pains ICOP of idiopathic trigeminal neuralgia with concomitant continuous pain, painful posttraumatic trigeminal neuropathy or idiopathic painful trigeminal neuropathy) and written informed consent will be obtained. The screening and baseline procedures include medical history review, clinical examinations, tests and administration of questionnaires. Instructions will be given for the completion of a Daily Symptom Diary (DSD) and other questionnaires at home or online. Participants who show compliance with 80 % completion of the DSD and who meet the pain score (inclusion criteria) for 4 weeks/28 days during the baseline period from Visit 0, will be randomly assigned to one of two groups either the investigational drug or placebo and will be scheduled for Visit 1.
The study drug is Erenumab 140 mg, SC injection. Participants will attend 6 clinic visits (Visit 0-Visit 5). After randomization and on Visit 1, the participant will receive the drug or placebo. This same treatment will be administered once a month for 3 months (3 cycles/12weeks).
- Conditions
- Trigeminal Neuropathy
- Being tested
- Erenumab-Aooe, Placebo
- Keywords
- Trigeminal neuropathic pain, Trigeminal Nerve Injury, Idiopathic trigeminal neuralgia with continuous pain, Idiopathic painful trigeminal neuropathy, Trigeminal Nerve Diseases, Cranial Nerve Diseases, Calcitonin Gene-Related Peptide Receptor Antagonists, CGRP Receptor Antagonist, Erenumab, Neuralgia, Face Pain, Physiological effects of drugs, Trigeminal Nerve Trauma
- Medical subject headings
- Trigeminal Nerve Diseases, Trigeminal Nerve Injuries, Cranial Nerve Diseases, Neuralgia, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erenumab-AooeDrug
Also called Aimovig
Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
PlaceboOther
Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Erenumab-aooe | Active comparator | Erenumab-aooe 140 mg/ml. Subcutaneous injection. Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
Other Name: Aimovig® Receives: Drug: Erenumab-Aooe |
| Placebo | Placebo comparator | Placebo. Subcutaneous injection.Administered once every 4 weeks/28 days at visit 1, visit 2 andvisit 3 for a total of 3 cycles.
Other name: Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of >= 30% Reduction in the Monthly (28 Days) Average Pain Score From Baseline to Visit 4, Compared to Placebo.
Assessment of the efficacy of erenumab-aooe in the proportion of participants that achieve >=30% reduction (Yes/no) in monthly (28 days) average pain score from baseline to Visit 4 (the last monthly treatment cycle), compared to placebo. The daily pain intensity score will be measured on a 11-point (0-10) numeric rating scale (NPRS) and reported in the Daily Symptom Diary (DSD). The monthly mean pain intensity score will be determined from baseline (4 weeks/28 days), for each month during the 12 weeks of treatment.
Measured: From Visit 0 (Baseline phase/Study day 0) to Visit 4 (Study day 112 +/- 7)
Secondary outcomes (6)
Efficacy of Erenumab-aooe Compared to Placebo on the Reduction in Monthly Average Daily Pain Score From Baseline to the End of 12-week Treatment Period.
Comparison of erenumab-aooe with placebo in the reduction of pain score from baseline continuously through to the end of 12 weeks (Visit 4).
Measured: From Visit 0 (Baseline phase/Study day 0) to Visit 4 (study day 112 +/- 7)
Change of >= 30% Reduction in the Monthly (28 Days) Average Pain Score Compared to Placebo From Baseline to Visit 5.
Assess the efficacy of erenumab-aooe compared to placebo on the proportion of subjects who achieved a least 30% reduction in the monthly average daily pain score from baseline to Visit 5 (follow-up/final visit).
Measured: From Visit 0 (Baseline phase/Study day 0) to Visit 5 ( study day 140 +/- 7)
Change in Participant Ratings Compared to Placebo for Improving Physical Function and Health Related Quality of Life in Patients With Trigeminal Neuropathic Pain Measured by the Penn Facial Pain Scale-Revised.
Efficacy of erenumab-aooe compared to placebo in improvement on burden/disability of daily activities related to trigeminal neuropathic pain (e.g. chewing, eating, talking, touching) measured by the Penn Facial Pain Scale-Revised. 12 items. The higher the score the more pain and disability.
Measured: Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7
Change in Graded Chronic Pain Scale (GCPS) Outcomes During Erenumab-aooe Treatment, After Treatment and Compared to Placebo.
The GCPS includes 7 items and assesses 2 dimensions of pain, pain intensity and pain-related disability. A higher grade means a worse outcome.
Measured: Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7
Change in the Hospital Anxiety and Depression Scale (HADS). Anxiety and Depression Score Change During Erenumab-aooe Treatment, After Treatment and Compared to Placebo.
The HADS evaluates anxiety (7 items) and depression (7 items) with a 14-item instrument assessing symptoms on a 4-point scale rated from 0 "not at all" to 3 "very often indeed". Responses provide separate scores for anxiety and depression. A higher score means a worse outcome.
Measured: Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7
Change in Impression of Overall Status Measured by the Patient Global Impression of Change (PGIC) During Erenumab-aooe Treatment, After Treatment and Compared to Placebo.
The PGIC measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start31 May 2022
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Why it stopped: Low enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Trigeminal NeuropathyStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Marcela Romero Reyes, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142228
- Sponsor's protocol ID
- HP-00097072
- Status last verified
- Mar 2024
- First submitted
- 29 Oct 2021
- Last updated
- 22 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mignogna MD, Fedele S. The neglected global burden of chronic oral diseases. J Dent Res. 2006 May;85(5):390-1. doi: 10.1177/154405910608500501. No abstract available.
PubMed 16632750Baad-Hansen L, Leijon G, Svensson P, List T. Comparison of clinical findings and psychosocial factors in patients with atypical odontalgia and temporomandibular disorders. J Orofac Pain. 2008 Winter;22(1):7-14.
PubMed 18351030Penarrocha MA, Penarrocha D, Bagan JV, Penarrocha M. Post-traumatic trigeminal neuropathy. A study of 63 cases. Med Oral Patol Oral Cir Bucal. 2012 Mar 1;17(2):e297-300. doi: 10.4317/medoral.17401.
PubMed 22143689Smith JG, Elias LA, Yilmaz Z, Barker S, Shah K, Shah S, Renton T. The psychosocial and affective burden of posttraumatic neuropathy following injuries to the trigeminal nerve. J Orofac Pain. 2013 Fall;27(4):293-303. doi: 10.11607/jop.1056.
PubMed 24171179Baad-Hansen L, Benoliel R. Neuropathic orofacial pain: Facts and fiction. Cephalalgia. 2017 Jun;37(7):670-679. doi: 10.1177/0333102417706310. Epub 2017 Apr 12.
PubMed 28403646Romero-Reyes M, Uyanik JM. Orofacial pain management: current perspectives. J Pain Res. 2014 Feb 21;7:99-115. doi: 10.2147/JPR.S37593. eCollection 2014.
PubMed 24591846International Classification of Orofacial Pain, 1st edition (ICOP). Cephalalgia. 2020 Feb;40(2):129-221. doi: 10.1177/0333102419893823. No abstract available.
PubMed 32103673Lewis MA, Sankar V, De Laat A, Benoliel R. Management of neuropathic orofacial pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Mar;103 Suppl:S32.e1-24. doi: 10.1016/j.tripleo.2006.10.014.
PubMed 17379152McQuay HJ, Tramer M, Nye BA, Carroll D, Wiffen PJ, Moore RA. A systematic review of antidepressants in neuropathic pain. Pain. 1996 Dec;68(2-3):217-27. doi: 10.1016/s0304-3959(96)03140-5.
PubMed 9121808McQuay H, Carroll D, Jadad AR, Wiffen P, Moore A. Anticonvulsant drugs for management of pain: a systematic review. BMJ. 1995 Oct 21;311(7012):1047-52. doi: 10.1136/bmj.311.7012.1047.
PubMed 7580659Dworkin RH, O'Connor AB, Audette J, Baron R, Gourlay GK, Haanpaa ML, Kent JL, Krane EJ, Lebel AA, Levy RM, Mackey SC, Mayer J, Miaskowski C, Raja SN, Rice AS, Schmader KE, Stacey B, Stanos S, Treede RD, Turk DC, Walco GA, Wells CD. Recommendations for the pharmacological management of neuropathic pain: an overview and literature update. Mayo Clin Proc. 2010 Mar;85(3 Suppl):S3-14. doi: 10.4065/mcp.2009.0649.
PubMed 20194146Zakrzewska JM. Medical management of trigeminal neuropathic pains. Expert Opin Pharmacother. 2010 Jun;11(8):1239-54. doi: 10.1517/14656561003767449.
PubMed 20426709Edvinsson L. The CGRP Pathway in Migraine as a Viable Target for Therapies. Headache. 2018 May;58 Suppl 1:33-47. doi: 10.1111/head.13305.
PubMed 29697153King CT, Gegg CV, Hu SN, Sen Lu H, Chan BM, Berry KA, Brankow DW, Boone TJ, Kezunovic N, Kelley MR, Shi L, Xu C. Discovery of the Migraine Prevention Therapeutic Aimovig (Erenumab), the First FDA-Approved Antibody against a G-Protein-Coupled Receptor. ACS Pharmacol Transl Sci. 2019 Sep 3;2(6):485-490. doi: 10.1021/acsptsci.9b00061. eCollection 2019 Dec 13.
PubMed 32259079Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280-2287. doi: 10.1016/S0140-6736(18)32534-0. Epub 2018 Oct 22.
PubMed 30360965
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erenumab as a Therapeutic Approach for the Management of Trigeminal Neuropathic Pain (TNP)
- ClinicalTrials.gov ID
- NCT05142228
- Acronym / sponsor ID
- HP-00097072
- Conditions
- Trigeminal Neuropathy
- Keywords
- Trigeminal neuropathic pain, Trigeminal Nerve Injury, Idiopathic trigeminal neuralgia with continuous pain, Idiopathic painful trigeminal neuropathy, Trigeminal Nerve Diseases, Cranial Nerve Diseases, Calcitonin Gene-Related Peptide Receptor Antagonists, CGRP Receptor Antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment rate
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 31 May 2022 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Posted 22 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single center, placebo-controlled, double blind, randomized, phase II pilot to evaluate the efficacy of erenumab-aooe in the management of trigeminal neuropathic pain comparing erenumab-aooe vs Placebo.
A total of 40 patients (20 each arm) aged 18-65 years old of either sex, and any race or ethnicity, presenting trigeminal neuropathic pain will be randomly assigned in a 1:1 parallel, double-blind clinical trial, to receive either Erenumab or placebo. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks. Changes in pain intensity and other pain related outcomes of trigeminal neuropathic pain will be assessed. Blood samples will be collected, and participants will need to keep a daily symptom diary and answer some other questionnaires.
Detailed description
TNP are a considerable burden and affects significantly the quality of life of the sufferer. There are medications for their management but while they may work for some patients, may not work for the others; in addition, side effects may be present for some patients with the need to decrease dosage to not optimal levels. Furthermore, the indications of these drugs are for other neuropathic pain disorders and currently there is no medication specifically indicated for the management of TNP based on its molecular pathophysiology.
The calcitonin gene-related peptide (CGRP) is a key neuropeptide involved in migraine pathophysiology. There is evidence showing that CGRP has a role in other disorders mediated by the trigeminal system in addition to migraine; CGRP has shown to have a role in orofacial pain such as in TMD and in trigeminal neuropathic pain. Erenumab-aooe is the first antibody therapeutic targeting the CGRP receptor with FDA approval for migraine prevention that is well tolerated and with a good safety profile. Therefore, the scientific premise for this study is that inhibiting the CGRP pathway in trigeminal neuropathic pain will decrease pain and pain related outcomes in a safe and well tolerated manner for this patient population.
Potential participants will be pre-screened at the Brotman Facial Pain clinic, at the Oral and Maxillofacial Surgery Clinic both at the University of Maryland, School of Dentistry, at the Pain Medicine Clinic at the University of Maryland, School of Medicine or by telephone; those willing to participate will be scheduled for a screening and baseline visit (Visit 0). During this visit, potential participants will be evaluated for eligibility for trigeminal neuropathic pain (subjects with diagnosis based on the International classification of headache disorders ICHD-3 and International classification of Orofacial Pains ICOP of idiopathic trigeminal neuralgia with concomitant continuous pain, painful posttraumatic trigeminal neuropathy or idiopathic painful trigeminal neuropathy) and written informed consent will be obtained. The screening and baseline procedures include medical history review, clinical examinations, tests and administration of questionnaires. Instructions will be given for the completion of a Daily Symptom Diary (DSD) and other questionnaires at home or online. Participants who show compliance with 80 % completion of the DSD and who meet the pain score (inclusion criteria) for 4 weeks/28 days during the baseline period from Visit 0, will be randomly assigned to one of two groups either the investigational drug or placebo and will be scheduled for Visit 1.
The study drug is Erenumab 140 mg, SC injection. Participants will attend 6 clinic visits (Visit 0-Visit 5). After randomization and on Visit 1, the participant will receive the drug or placebo. This same treatment will be administered once a month for 3 months (3 cycles/12weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erenumab-aooe | Active comparator | Drug: Erenumab-AooeErenumab-aooe 140 mg/ml. Subcutaneous injection. Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles. Other Name: Aimovig® |
| Placebo | Placebo comparator | Other: PlaceboPlacebo. Subcutaneous injection.Administered once every 4 weeks/28 days at visit 1, visit 2 andvisit 3 for a total of 3 cycles. Other name: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Key exclusion criteria (21 listed)
- Participants with a history of congestive heart failure or uncontrolled diabetes.
- Participants with serious hepatic, respiratory, hematologic or immunologic illnesses, an unstable cardiovascular disease, or any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or Erenumab or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the participant inappropriate for entry into this trial.
- Participants with high blood pressure, uncontrolled high blood pressure, malignant disease, chronic constipation, any malabsorption disorders such as IBSc or any other severe acute or chronic medical or psychiatric condition (major depression, schizophrenia, dementia) or laboratory finding that may increase the risk associated with trial participation with Erenumab, that in the judgement of the investigators would interfere with study assessments and/or would make the participant inappropriate for entry into this trial.
- Participants with active malignancy of any type or a history a malignancy (with exception of participants with malignancy surgically removed with no evidence of recurrence within 5 years before enrollment.
- Participants with evidence or a history of drug or alcohol abuse within the past 12 months or has been diagnosed with a substance abuse disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erenumab-AooeAlso: AimovigAdministered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles. | Drug | Erenumab-aooe |
| PlaceboAdministered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles. | Other | Placebo |
Primary outcome
Change of >= 30% Reduction in the Monthly (28 Days) Average Pain Score From Baseline to Visit 4, Compared to Placebo.
Time frame: From Visit 0 (Baseline phase/Study day 0) to Visit 4 (Study day 112 +/- 7)
Assessment of the efficacy of erenumab-aooe in the proportion of participants that achieve >=30% reduction (Yes/no) in monthly (28 days) average pain score from baseline to Visit 4 (the last monthly treatment cycle), compared to placebo. The daily pain intensity score will be measured on a 11-point (0-10) numeric rating scale (NPRS) and reported in the Daily Symptom Diary (DSD). The monthly mean pain intensity score will be determined from baseline (4 weeks/28 days), for each month during the 12 weeks of treatment.
6 secondary outcomes
Efficacy of Erenumab-aooe Compared to Placebo on the Reduction in Monthly Average Daily Pain Score From Baseline to the End of 12-week Treatment Period.
Time frame: From Visit 0 (Baseline phase/Study day 0) to Visit 4 (study day 112 +/- 7)
Change of >= 30% Reduction in the Monthly (28 Days) Average Pain Score Compared to Placebo From Baseline to Visit 5.
Time frame: From Visit 0 (Baseline phase/Study day 0) to Visit 5 ( study day 140 +/- 7)
Change in Participant Ratings Compared to Placebo for Improving Physical Function and Health Related Quality of Life in Patients With Trigeminal Neuropathic Pain Measured by the Penn Facial Pain Scale-Revised.
Time frame: Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7
Change in Graded Chronic Pain Scale (GCPS) Outcomes During Erenumab-aooe Treatment, After Treatment and Compared to Placebo.
Time frame: Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7
Change in the Hospital Anxiety and Depression Scale (HADS). Anxiety and Depression Score Change During Erenumab-aooe Treatment, After Treatment and Compared to Placebo.
Time frame: Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7
Change in Impression of Overall Status Measured by the Patient Global Impression of Change (PGIC) During Erenumab-aooe Treatment, After Treatment and Compared to Placebo.
Time frame: Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16632750Mignogna MD, Fedele S. The neglected global burden of chronic oral diseases. J Dent Res. 2006 May;85(5):390-1. doi: 10.1177/154405910608500501. No abstract available.
- Background: PubMed 18351030Baad-Hansen L, Leijon G, Svensson P, List T. Comparison of clinical findings and psychosocial factors in patients with atypical odontalgia and temporomandibular disorders. J Orofac Pain. 2008 Winter;22(1):7-14.
- Background: PubMed 22143689Penarrocha MA, Penarrocha D, Bagan JV, Penarrocha M. Post-traumatic trigeminal neuropathy. A study of 63 cases. Med Oral Patol Oral Cir Bucal. 2012 Mar 1;17(2):e297-300. doi: 10.4317/medoral.17401.
- Background: PubMed 24171179Smith JG, Elias LA, Yilmaz Z, Barker S, Shah K, Shah S, Renton T. The psychosocial and affective burden of posttraumatic neuropathy following injuries to the trigeminal nerve. J Orofac Pain. 2013 Fall;27(4):293-303. doi: 10.11607/jop.1056.
- Background: PubMed 28403646Baad-Hansen L, Benoliel R. Neuropathic orofacial pain: Facts and fiction. Cephalalgia. 2017 Jun;37(7):670-679. doi: 10.1177/0333102417706310. Epub 2017 Apr 12.
- Background: PubMed 24591846Romero-Reyes M, Uyanik JM. Orofacial pain management: current perspectives. J Pain Res. 2014 Feb 21;7:99-115. doi: 10.2147/JPR.S37593. eCollection 2014.
- Background: PubMed 32103673International Classification of Orofacial Pain, 1st edition (ICOP). Cephalalgia. 2020 Feb;40(2):129-221. doi: 10.1177/0333102419893823. No abstract available.
- Background: PubMed 17379152Lewis MA, Sankar V, De Laat A, Benoliel R. Management of neuropathic orofacial pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Mar;103 Suppl:S32.e1-24. doi: 10.1016/j.tripleo.2006.10.014.
- Background: PubMed 9121808McQuay HJ, Tramer M, Nye BA, Carroll D, Wiffen PJ, Moore RA. A systematic review of antidepressants in neuropathic pain. Pain. 1996 Dec;68(2-3):217-27. doi: 10.1016/s0304-3959(96)03140-5.
- Background: PubMed 7580659McQuay H, Carroll D, Jadad AR, Wiffen P, Moore A. Anticonvulsant drugs for management of pain: a systematic review. BMJ. 1995 Oct 21;311(7012):1047-52. doi: 10.1136/bmj.311.7012.1047.
- Background: PubMed 20194146Dworkin RH, O'Connor AB, Audette J, Baron R, Gourlay GK, Haanpaa ML, Kent JL, Krane EJ, Lebel AA, Levy RM, Mackey SC, Mayer J, Miaskowski C, Raja SN, Rice AS, Schmader KE, Stacey B, Stanos S, Treede RD, Turk DC, Walco GA, Wells CD. Recommendations for the pharmacological management of neuropathic pain: an overview and literature update. Mayo Clin Proc. 2010 Mar;85(3 Suppl):S3-14. doi: 10.4065/mcp.2009.0649.
- Background: PubMed 20426709Zakrzewska JM. Medical management of trigeminal neuropathic pains. Expert Opin Pharmacother. 2010 Jun;11(8):1239-54. doi: 10.1517/14656561003767449.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erenumab-Aooe in people with Trigeminal Neuropathy, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of >= 30% Reduction in the Monthly (28 Days) Average Pain Score From Baseline to Visit 4, Compared to Placebo. (time frame: From Visit 0 (Baseline phase/Study day 0) to Visit 4 (Study day 112 +/- 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05142228, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.