Occipital NeuralgiaPhase 1NCT04051203
Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia
A Phase 1 study testing Autologous Platelet Rich Plasma Injection, Depo-Medrol and lidocaine and Normal Saline in people with Occipital Neuralgia and Headache, run by University of Calgary at 1 site in Canada.
Trial summary
This study is a randomized controlled trial, assessing the effect of a single platelet rich plasma (PRP) injection in post traumatic (concussive) greater occipital neuralgia. This study will compare the effects of a single PRP injection to injection with steroid and anesthetic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occipital Neuralgia, Headache
- What is being tested?
- Autologous Platelet Rich Plasma Injection, Depo-Medrol and lidocaine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2019to 1 Dec 2023
- Phase
- Phase 1
- 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
Who may be able to join
- Eligible participants will be males or females at least 18 years of age who suffer from post-traumatic headaches secondary to GON. Patients must fulfill the ICHD-3 criteria in establishing a diagnosis of GON. This diagnosis will be established by an experienced Physiatrist with extensive experience in headache and related disorders. To meet this criteria, patients must have experienced previous successful temporary relief with local anesthetic or steroid injection surrounding the GON in the past, but have not received local steroid injection within past 3 months. Pre-treatment numerical pain rating scale for daily headache intensity must be ≥4/10, with a headache frequency ≥10 days/month. Possible secondary causes of ON must be ruled out with reasonable level of investigation prior to enrollment.
Who cannot join
- Inability to provide informed consent; history of surgery in the occipital region; unstable psychiatric or medical condition; rheumatologic or inflammatory disorders; widespread neurologic disorders (eg. MS); coagulopathy; immunosuppression; active cancer; herpes zoster infection in last 6 months; pregnancy; steroid or other local GON or LON infiltration in past 3 months.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Foothills Medical Center, Main Floor Special Services
Calgary, Alberta, T2N2T9
About this study
Official title: Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia: A Randomized Controlled Pilot Study
This study is a randomized controlled trial, assessing the effect of a single platelet rich plasma (PRP) injection in post traumatic (concussive) greater occipital neuralgia. This study will compare the effects of a single PRP injection to injection with steroid and anesthetic. There will also be a third arm to the study, in which patients will receive an injection with normal saline. This study will assess the severity and frequency of headache symptoms before and after receiving the injection.
Read the detailed description
Each year, an estimated 69 million people suffer from traumatic brain injury/concussion worldwide. In most patients with concussion, symptoms improve within 3 months. However, in some persons, symptoms persist. The cause(s) of post-traumatic headache are not entirely clear, which limits treatment options. Sometimes, these headaches are caused by irritation to the greater occipital nerve, and pain originating from this area is called "greater occipital neuralgia". These headaches are often treated with steroid injections to the affected nerve. However, the effect of the injection is usually short lasting and may not provide adequate pain relief.
Therefore, other methods of treatment have been sought out. Platelet Rich Plasma (PRP) is an emerging biologic treatment. PRP contains high concentrations of platelets, growth factors, and anti-inflammatory molecules. PRP acts to reduce inflammation and encourage tissue repair at the site of injection. PRP is created by collecting a person's own blood, centrifuging it, and extracting the platelet-rich layer of plasma. This platelet rich mixture is then re-injected into the affected area. PRP is used as a safe and effective treatment in many fields, and is most commonly used in arthritis. PRP has recently been studied as a potential treatment for peripheral nerve disorders, such as carpal tunnel syndrome.
Post-injection, a daily headache diary provided via mobile application (Secure RedCap) available in iPhone or android device will be provided to record daily records of numeric pain rating scale, headache frequency and medication-use.
- Conditions
- Occipital Neuralgia, Headache
- Being tested
- Autologous Platelet Rich Plasma Injection, Depo-Medrol and lidocaine, Normal Saline
- Keywords
- GON, greater occipital neuralgia, post traumatic headache, post concussive headache
- Medical subject headings
- Headache, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet Rich Plasma InjectionBiological
60mL of blood will be drawn from the antecubital vein and processed via centrifugation. Samples will be centrifuged as per manufacturer instructions, yielding 5mL of PRP.
Depo-Medrol and lidocaineDrug
Steroid injections will be prepared to include 20mg Depo-Medrol and 2mL 2% lidocaine.
Normal SalineOther
2mL normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Platelet Rich Plasma Injection | Experimental | PRP contains high concentrations of platelets, growth factors, and anti-inflammatory molecules. Receives: Biological: Autologous Platelet Rich Plasma Injection |
| Standard Treatment | Active comparator | Steroid and anesthetic injection: the clinical standard. Receives: Drug: Depo-Medrol and lidocaine |
| Normal Saline | Placebo comparator | Placebo injection, with no known treatment effects. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the feasibility of platelet-rich plasma for patients with post-traumatic greater occipital neuralgia
The feasibility will be determined based on recruitment (greater than 30% of those screened eligible), attendance (70% intervention appointment attendance), retention (70% complete study protocol), and the acceptability of the protocol
Measured: Screening, pre-injection to 3-months post injection
Evaluate the safety profile of platelet-rich plasma for the treatment of post-traumatic greater occipital neuralgia
Safety will be determined based on adverse reactions monitored through daily headache diary reporting and communication with the study team
Measured: from immediately post-injection to 3-months, daily recording
Secondary outcomes (4)
Change in headache severity as measured by the Numerical Pain Raiting Scale (NPRS)
This will be measured as a greater than a 2-point decrease on the NPRS at 3 months post-injection in the PRP group as compared to steroid and saline groups.
Measured: Pre-injection to 3 months post injection, daily recording.
Change in headache frequency (days per month with headache).
Using daily headache diaries, headache frequency will be collected.
Measured: Pre-injection to 3 months post injection, daily recording.
Headache Impact Test-6
A valid and reliable 6-item questionnaire for assessment of the impact of headaches across different diagnostic groups of headaches. The HIT-6 items measure the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological distress. The HIT-6 also measures the severity of headache pain.
Measured: Pre-injection, 1 month, and 3 month time points.
Quality of Life in Following Brain Injury Questionnaire
The QOLIBRI (Quality of Life after Brain Injury) is the first instrument specifically developed to assess health-related quality of life (HRQoL) of individuals after traumatic brain injury. The QOLIBRI is a comprehensive questionnaire with 37 items covering six dimensions of HRQoL after TBI. The questionnaire provides a profile of quality of life together with a total score.
Measured: Pre-injection, 1 month, and 3 month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Feb 2019
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Occipital NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized controlled trial, participants are randomly assigned to one of three groups; an autologous PRP injection, a steroid injection, or normal saline.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051203
- Sponsor's protocol ID
- REB18-1368
- Status last verified
- Oct 2023
- First submitted
- 23 Jul 2019
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan, all participant data will be kept on a secured REDCap database.
Publications
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Hyder AA, Wunderlich CA, Puvanachandra P, Gururaj G, Kobusingye OC. The impact of traumatic brain injuries: a global perspective. NeuroRehabilitation. 2007;22(5):341-53.
PubMed 18162698Dewan MC, Rattani A, Gupta S, Baticulon RE, Hung YC, Punchak M, Agrawal A, Adeleye AO, Shrime MG, Rubiano AM, Rosenfeld JV, Park KB. Estimating the global incidence of traumatic brain injury. J Neurosurg. 2018 Apr 27;130(4):1080-1097. doi: 10.3171/2017.10.JNS17352. Print 2019 Apr 1.
PubMed 29701556Coronado VG, Xu L, Basavaraju SV, McGuire LC, Wald MM, Faul MD, Guzman BR, Hemphill JD; Centers for Disease Control and Prevention (CDC). Surveillance for traumatic brain injury-related deaths--United States, 1997-2007. MMWR Surveill Summ. 2011 May 6;60(5):1-32.
PubMed 21544045Ponsford JL, Downing MG, Olver J, Ponsford M, Acher R, Carty M, Spitz G. Longitudinal follow-up of patients with traumatic brain injury: outcome at two, five, and ten years post-injury. J Neurotrauma. 2014 Jan 1;31(1):64-77. doi: 10.1089/neu.2013.2997.
PubMed 23889321Lundin A, de Boussard C, Edman G, Borg J. Symptoms and disability until 3 months after mild TBI. Brain Inj. 2006 Jul;20(8):799-806. doi: 10.1080/02699050600744327.
PubMed 17060147Hoffman JM, Lucas S, Dikmen S, Braden CA, Brown AW, Brunner R, Diaz-Arrastia R, Walker WC, Watanabe TK, Bell KR. Natural history of headache after traumatic brain injury. J Neurotrauma. 2011 Sep;28(9):1719-25. doi: 10.1089/neu.2011.1914. Epub 2011 Aug 29.
PubMed 21732765Hammond SR, Danta G. Occipital neuralgia. Clin Exp Neurol. 1978;15:258-70.
PubMed 756019Dougherty C. Occipital neuralgia. Curr Pain Headache Rep. 2014 May;18(5):411. doi: 10.1007/s11916-014-0411-x.
PubMed 24737457Ward JB. Greater occipital nerve block. Semin Neurol. 2003 Mar;23(1):59-62. doi: 10.1055/s-2003-40752.
PubMed 12870106Anthony M. Headache and the greater occipital nerve. Clin Neurol Neurosurg. 1992;94(4):297-301. doi: 10.1016/0303-8467(92)90177-5.
PubMed 1335856Choi I, Jeon SR. Neuralgias of the Head: Occipital Neuralgia. J Korean Med Sci. 2016 Apr;31(4):479-88. doi: 10.3346/jkms.2016.31.4.479. Epub 2016 Mar 9.
PubMed 27051229Kuhn WF, Kuhn SC, Gilberstadt H. Occipital neuralgias: clinical recognition of a complicated headache. A case series and literature review. J Orofac Pain. 1997 Spring;11(2):158-65.
PubMed 10332322Laver L, Marom N, Dnyanesh L, Mei-Dan O, Espregueira-Mendes J, Gobbi A. PRP for Degenerative Cartilage Disease: A Systematic Review of Clinical Studies. Cartilage. 2017 Oct;8(4):341-364. doi: 10.1177/1947603516670709. Epub 2016 Sep 1.
PubMed 28317389Sampson S, Gerhardt M, Mandelbaum B. Platelet rich plasma injection grafts for musculoskeletal injuries: a review. Curr Rev Musculoskelet Med. 2008 Dec;1(3-4):165-74. doi: 10.1007/s12178-008-9032-5.
PubMed 19468902
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04051203
- Acronym / sponsor ID
- REB18-1368
- Conditions
- Occipital Neuralgia, Headache
- Keywords
- GON, greater occipital neuralgia, post traumatic headache, post concussive headache
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 9 Aug 2019 (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 study is a randomized controlled trial, assessing the effect of a single platelet rich plasma (PRP) injection in post traumatic (concussive) greater occipital neuralgia. This study will compare the effects of a single PRP injection to injection with steroid and anesthetic. There will also be a third arm to the study, in which patients will receive an injection with normal saline. This study will assess the severity and frequency of headache symptoms before and after receiving the injection.
Detailed description
Each year, an estimated 69 million people suffer from traumatic brain injury/concussion worldwide. In most patients with concussion, symptoms improve within 3 months. However, in some persons, symptoms persist. The cause(s) of post-traumatic headache are not entirely clear, which limits treatment options. Sometimes, these headaches are caused by irritation to the greater occipital nerve, and pain originating from this area is called "greater occipital neuralgia". These headaches are often treated with steroid injections to the affected nerve. However, the effect of the injection is usually short lasting and may not provide adequate pain relief.
Therefore, other methods of treatment have been sought out. Platelet Rich Plasma (PRP) is an emerging biologic treatment. PRP contains high concentrations of platelets, growth factors, and anti-inflammatory molecules. PRP acts to reduce inflammation and encourage tissue repair at the site of injection. PRP is created by collecting a person's own blood, centrifuging it, and extracting the platelet-rich layer of plasma. This platelet rich mixture is then re-injected into the affected area. PRP is used as a safe and effective treatment in many fields, and is most commonly used in arthritis. PRP has recently been studied as a potential treatment for peripheral nerve disorders, such as carpal tunnel syndrome.
Post-injection, a daily headache diary provided via mobile application (Secure RedCap) available in iPhone or android device will be provided to record daily records of numeric pain rating scale, headache frequency and medication-use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized controlled trial, participants are randomly assigned to one of three groups; an autologous PRP injection, a steroid injection, or normal saline.
| Arm | Type | Receives |
|---|---|---|
| Autologous Platelet Rich Plasma Injection | Experimental | Biological: Autologous Platelet Rich Plasma InjectionPRP contains high concentrations of platelets, growth factors, and anti-inflammatory molecules. |
| Standard Treatment | Active comparator | Drug: Depo-Medrol and lidocaineSteroid and anesthetic injection: the clinical standard. |
| Normal Saline | Placebo comparator | Other: Normal SalinePlacebo injection, with no known treatment effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants will be males or females at least 18 years of age who suffer from post-traumatic headaches secondary to GON. Patients must fulfill the ICHD-3 criteria in establishing a diagnosis of GON. This diagnosis will be established by an experienced Physiatrist with extensive experience in headache and related disorders. To meet this criteria, patients must have experienced previous successful temporary relief with local anesthetic or steroid injection surrounding the GON in the past, but have not received local steroid injection within past 3 months. Pre-treatment numerical pain rating scale for daily headache intensity must be ≥4/10, with a headache frequency ≥10 days/month. Possible secondary causes of ON must be ruled out with reasonable level of investigation prior to enrollment.
Key exclusion criteria (1 listed)
- Inability to provide informed consent; history of surgery in the occipital region; unstable psychiatric or medical condition; rheumatologic or inflammatory disorders; widespread neurologic disorders (eg. MS); coagulopathy; immunosuppression; active cancer; herpes zoster infection in last 6 months; pregnancy; steroid or other local GON or LON infiltration in past 3 months.
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 |
|---|---|---|
| Autologous Platelet Rich Plasma Injection60mL of blood will be drawn from the antecubital vein and processed via centrifugation. Samples will be centrifuged as per manufacturer instructions, yielding 5mL of PRP. | Biological | Autologous Platelet Rich Plasma Injection |
| Depo-Medrol and lidocaineSteroid injections will be prepared to include 20mg Depo-Medrol and 2mL 2% lidocaine. | Drug | Standard Treatment |
| Normal Saline2mL normal saline. | Other | Normal Saline |
Primary outcome
Evaluate the feasibility of platelet-rich plasma for patients with post-traumatic greater occipital neuralgia
Time frame: Screening, pre-injection to 3-months post injection
The feasibility will be determined based on recruitment (greater than 30% of those screened eligible), attendance (70% intervention appointment attendance), retention (70% complete study protocol), and the acceptability of the protocol
Evaluate the safety profile of platelet-rich plasma for the treatment of post-traumatic greater occipital neuralgia
Time frame: from immediately post-injection to 3-months, daily recording
Safety will be determined based on adverse reactions monitored through daily headache diary reporting and communication with the study team
4 secondary outcomes
Change in headache severity as measured by the Numerical Pain Raiting Scale (NPRS)
Time frame: Pre-injection to 3 months post injection, daily recording.
Change in headache frequency (days per month with headache).
Time frame: Pre-injection to 3 months post injection, daily recording.
Headache Impact Test-6
Time frame: Pre-injection, 1 month, and 3 month time points.
Quality of Life in Following Brain Injury Questionnaire
Time frame: Pre-injection, 1 month, and 3 month follow-ups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 18162698Hyder AA, Wunderlich CA, Puvanachandra P, Gururaj G, Kobusingye OC. The impact of traumatic brain injuries: a global perspective. NeuroRehabilitation. 2007;22(5):341-53.
- Background: PubMed 29701556Dewan MC, Rattani A, Gupta S, Baticulon RE, Hung YC, Punchak M, Agrawal A, Adeleye AO, Shrime MG, Rubiano AM, Rosenfeld JV, Park KB. Estimating the global incidence of traumatic brain injury. J Neurosurg. 2018 Apr 27;130(4):1080-1097. doi: 10.3171/2017.10.JNS17352. Print 2019 Apr 1.
- Background: PubMed 21544045Coronado VG, Xu L, Basavaraju SV, McGuire LC, Wald MM, Faul MD, Guzman BR, Hemphill JD; Centers for Disease Control and Prevention (CDC). Surveillance for traumatic brain injury-related deaths--United States, 1997-2007. MMWR Surveill Summ. 2011 May 6;60(5):1-32.
- Background: PubMed 23889321Ponsford JL, Downing MG, Olver J, Ponsford M, Acher R, Carty M, Spitz G. Longitudinal follow-up of patients with traumatic brain injury: outcome at two, five, and ten years post-injury. J Neurotrauma. 2014 Jan 1;31(1):64-77. doi: 10.1089/neu.2013.2997.
- Background: PubMed 17060147Lundin A, de Boussard C, Edman G, Borg J. Symptoms and disability until 3 months after mild TBI. Brain Inj. 2006 Jul;20(8):799-806. doi: 10.1080/02699050600744327.
- Background: PubMed 21732765Hoffman JM, Lucas S, Dikmen S, Braden CA, Brown AW, Brunner R, Diaz-Arrastia R, Walker WC, Watanabe TK, Bell KR. Natural history of headache after traumatic brain injury. J Neurotrauma. 2011 Sep;28(9):1719-25. doi: 10.1089/neu.2011.1914. Epub 2011 Aug 29.
- Background: PubMed 756019Hammond SR, Danta G. Occipital neuralgia. Clin Exp Neurol. 1978;15:258-70.
- Background: PubMed 24737457Dougherty C. Occipital neuralgia. Curr Pain Headache Rep. 2014 May;18(5):411. doi: 10.1007/s11916-014-0411-x.
- Background: PubMed 12870106Ward JB. Greater occipital nerve block. Semin Neurol. 2003 Mar;23(1):59-62. doi: 10.1055/s-2003-40752.
- Background: PubMed 1335856Anthony M. Headache and the greater occipital nerve. Clin Neurol Neurosurg. 1992;94(4):297-301. doi: 10.1016/0303-8467(92)90177-5.
- Background: PubMed 27051229Choi I, Jeon SR. Neuralgias of the Head: Occipital Neuralgia. J Korean Med Sci. 2016 Apr;31(4):479-88. doi: 10.3346/jkms.2016.31.4.479. Epub 2016 Mar 9.
- Individual participant dataSharing planned: No. There is no plan, all participant data will be kept on a secured REDCap database.
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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 1 study testing Autologous Platelet Rich Plasma Injection, Depo-Medrol and lidocaine and Normal Saline in people with Occipital Neuralgia and Headache, run by University of Calgary at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Feb 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the feasibility of platelet-rich plasma for patients with post-traumatic greater occipital neuralgia (time frame: Screening, pre-injection to 3-months post injection). The study lists 2 primary outcomes in all. 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 NCT04051203, which also lists 38 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 6 Feb 2024.