Chronic MigraineNCT05536050
Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia
An observational study of Chronic Migraine and Fibromyalgia, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This research aims to look at the effect of low-dose naltrexone on the severity and frequency of attacks in people with chronic migraine with or without new daily persistent headache and fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Migraine, Fibromyalgia, New Daily Persistent Headache
- What is being tested?
- Migraine diary and Questionnaires
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be screened and enrolled by study personnel either during their visit with their referring physician, or remotely.
Who may be able to join
- Subjects will be adults of all genders ages 18 and older.
- Patients with a diagnosis of CM (with or without NDPH) by IHC-3 criteria, diagnosed by a certified headache specialist.
- Subjects who received a new prescription for LDN
- Fibromyalgia-diagnosed according to Fibromyalgia Rapid Screening Tool
- Subjects should be on stable headache and migraine preventives for the past 2 months with no plans to change medication for the next 4 months.
- Subjects willing to maintain a headache/migraine diary one month prior to taking medication and while taking the medication, either physical or electronic diary of their choice.
- Subjects willing to fill out pre and post intervention surveys
- Subjects willing to comply with planned follow up phone calls and visits.
Who cannot join
- Not planning on follow up care with clinician.
- Patients with decreased decision-making capacity in which the investigator's opinion would interfere with the person's ability to provide informed consent and complete study questionnaires.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
Michael Marmura, MD, 215-955-2243, michael.marmura@jefferson.edu
Joshua B Katz, BA
About this study
Official title: Prospective Observational Pilot Study of Low-dose Naltrexone in Patients With Chronic Migraine With Comorbid Fibromyalgia
This research aims to look at the effect of low-dose naltrexone on the severity and frequency of attacks in people with chronic migraine with or without new daily persistent headache and fibromyalgia. A few studies suggest low-dose naltrexone is effective for fibromyalgia, but it has not been studied in patients with migraine and headaches. Our goal is to see if there is an improvement in either severity and frequency of attacks and overall impact on quality of life over a three-month period.
- Being tested
- Migraine diary and Questionnaires
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Migraine diary and QuestionnairesOther
Patients who already have a prescription for low-dose naltrexone will be administered questionnaires twice during the trial. Additionally, patients will maintain migraine diary for the duration of the trial.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness on migraine
Monthly migraine days
Measured: 9-12 weeks
Secondary outcomes (7)
Effectiveness on headache
Monthly headache days
Measured: 9-12 weeks
Intensity
Average peak intensity of migraine
Measured: 9-12 weeks
The Migraine Disability Assessment Test
Impact of migraine on daily life
Measured: 9-12 weeks
Migraine Specific Quality of Life Index
Impact of migraine and migraine treatment on quality of life
Measured: 9-12 weeks
Patient Health Questionnaire
Monitor depression and changes in signs/symptoms of depression
Measured: 9-12 weeks
Fibromyalgia Impact Questionnaire
Assess health status of patients with fibromyalgia
Measured: 9-12 weeks
Patients' Global Impression of Change
Assess patient's belief in efficacy of treatment
Measured: 9-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start28 Jul 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536050
- Sponsor's protocol ID
- 22D.486
- Status last verified
- Oct 2022
- First submitted
- 7 Sep 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Pilot Study of Low-dose Naltrexone in Patients With Chronic Migraine With Comorbid Fibromyalgia
- ClinicalTrials.gov ID
- NCT05536050
- Acronym / sponsor ID
- 22D.486
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aims to look at the effect of low-dose naltrexone on the severity and frequency of attacks in people with chronic migraine with or without new daily persistent headache and fibromyalgia. A few studies suggest low-dose naltrexone is effective for fibromyalgia, but it has not been studied in patients with migraine and headaches. Our goal is to see if there is an improvement in either severity and frequency of attacks and overall impact on quality of life over a three-month period.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be screened and enrolled by study personnel either during their visit with their referring physician, or remotely.
Key inclusion criteria (8 listed)
- Subjects will be adults of all genders ages 18 and older.
- Patients with a diagnosis of CM (with or without NDPH) by IHC-3 criteria, diagnosed by a certified headache specialist.
- Subjects who received a new prescription for LDN
- Fibromyalgia-diagnosed according to Fibromyalgia Rapid Screening Tool
- Subjects should be on stable headache and migraine preventives for the past 2 months with no plans to change medication for the next 4 months.
Key exclusion criteria (2 listed)
- Not planning on follow up care with clinician.
- Patients with decreased decision-making capacity in which the investigator's opinion would interfere with the person's ability to provide informed consent and complete study questionnaires.
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 |
|---|---|---|
| Migraine diary and QuestionnairesPatients who already have a prescription for low-dose naltrexone will be administered questionnaires twice during the trial. Additionally, patients will maintain migraine diary for the duration of the trial. | Other | – |
Primary outcome
Effectiveness on migraine
Time frame: 9-12 weeks
Monthly migraine days
7 secondary outcomes
Effectiveness on headache
Time frame: 9-12 weeks
Intensity
Time frame: 9-12 weeks
The Migraine Disability Assessment Test
Time frame: 9-12 weeks
Migraine Specific Quality of Life Index
Time frame: 9-12 weeks
Patient Health Questionnaire
Time frame: 9-12 weeks
Fibromyalgia Impact Questionnaire
Time frame: 9-12 weeks
Patients' Global Impression of Change
Time frame: 9-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Migraine and Fibromyalgia, run by Thomas Jefferson University 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Oct 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness on migraine (time frame: 9-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2022.