A Phase 4 interventional study of Botulinum toxin type A in Migraine, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Basic science
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Among 39 studies testing botulinum toxin type A in Migraine Disorders — 6 open to participants now, 10 under way, 5 of them phase 3. botulinum toxin type A · Migraine Disorders.
Among the 39 studies testing botulinum toxin type A in Migraine Disorders, this one is the 28th largest by enrollment, is one of 3 that started in 2017, is one of 12 in phase 4, and was the 21st registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →6 of the 39 studies testing botulinum toxin type A in Migraine Disorders are open now, in 2 countries. Recruiting first, the newest first:
Cairo University · Sites in Egypt
Ages 18–65
Naval Medical Center Camp Lejeune · Sites in United States
Ages 18–89
Assiut University
Ages 18–65
Assiut University
Ages 18–65
Beni-Suef University · Sites in Egypt
Ages 18+
By country, each count listing its studies:
botulinum toxin type A: first FDA approval 1991 (BOTOX COSMETIC), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 9 · Phase 3 14 · Phase 4 12
First in 2003; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 37 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 70 across the 39 interventional studies. Of the 25 that completed or were terminated, 17 (68%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 39 have an industry lead sponsor. The 10 most frequent:
Massachusetts General Hospital is the lead sponsor of 2,588 studies on the registry; 446 are open to participants now.
Of its 223 completed or terminated interventional studies of FDA-regulated products, 168 (75%) have results posted.
Massachusetts General Hospital has 5 studies filed under Migraine Disorders — fewer than ten, so there is no comparison to draw.
4 of the studies testing botulinum toxin type A in Migraine Disorders that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05598723Phase 3Naval Medical Center Camp LejeuneBOTOX® vs. XEOMIN® for Chronic Migraine | 2027-02-24 |
| NCT07018700Phase 3Merz Therapeutics GmbHA Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine | 2027-03 |
| NCT07018713Phase 3Merz Therapeutics GmbHA Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine | 2027-03 |
| NCT07837570Assiut UniversityComparison of the Effectiveness of Greater Occipital Nerve and Supratrochlear Nerve Pulsed Radiofrequency Versus Botulinum Toxin Type A Injection in Chronic Migraine | 2027-10 |
Add all 4 to your calendar (.ics) → With an account.
Among the 39 studies testing botulinum toxin type A in Migraine Disorders, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To compare Botox-treated and Botox-untreated symptomatic tissues (defined as areas where the head hurts and the pain is felt) of chronic migraine (CM) patients using molecular studies.
Eligible patients for migraine surgery will be injected unilaterally with Botox prior to surgery. The effects of Botox on tissues will be evaluated.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will be injected with Botulinum toxin on one side of the back of the head.
Drug: Botulinum toxin type A
Injection of Botulinum toxin type A in back of head
Also known as: Botox
Inflammatory Gene Expression in Chronic Migraine Patients With OnabotulinumtoxinA Injection Treatment Versus No Treatment
In this split-person study, patients with chronic bilateral occipital migraines scheduled for a study-unrelated migraine surgery (occipital nerve decompression surgery) had one side of their head undergo treatment with onabotulinumtoxinA injection, while the other side of the head underwent no treatment. Occipital periosteum tissue of both injected and uninjected sides was collected during migraine surgery for targeted transcriptome profiling and genome-wide epigenome analyses of inflammatory gene expression using NanoString of 594 genes (579 immunology-related genes involved in adaptive/innate response, lymphocyte activation, cytokine/chemokine/NF-kB/TNF/interferon signalling, neutrophils, macrophages, cytotoxic T, NK, Th1, B and dendritic cells, and 15 internal reference controls). The effects size (ratio of geometric means) of expression of gene expression was evaluated between injected and uninjected sides.
Time frame: One year
| Milestone | Treatment With Onabotulinumtoxin A Injection | No Treatment |
|---|---|---|
| Started | 37 | 37 |
| Split-person intervention | 32 | 32 |
| Migraine surgery | 31 | 31 |
| Completed | 31 | 31 |
| Not completed | 6 | 6 |
| Milestone | Treatment With Onabotulinumtoxin A Injection | No Treatment |
|---|---|---|
| Started | 31 | 31 |
| Completed | 18 | 18 |
| Not completed | 13 | 13 |
In this split-person study, patients with chronic bilateral occipital migraines scheduled for a study-unrelated migraine surgery (occipital nerve decompression surgery) had one side of their head undergo treatment with onabotulinumtoxinA injection, while the other side of the head underwent no treatment. Occipital periosteum tissue of both injected and uninjected sides was collected during migraine surgery for targeted transcriptome profiling and genome-wide epigenome analyses of inflammatory gene expression using NanoString of 594 genes (579 immunology-related genes involved in adaptive/innate response, lymphocyte activation, cytokine/chemokine/NF-kB/TNF/interferon signalling, neutrophils, macrophages, cytotoxic T, NK, Th1, B and dendritic cells, and 15 internal reference controls). The effects size (ratio of geometric means) of expression of gene expression was evaluated between injected and uninjected sides.
| mRNA units | Treatment With OnabotulinumtoxinA Injection | No Treatment |
|---|---|---|
| Inflammatory Gene Expression in Chronic Migraine Patients With OnabotulinumtoxinA Injection Treatment Versus No Treatment | 44.46156 (12.98994 to 137.8325) | 68.74241 (26.35755 to 191.9613) |
Collected over For each patient, from the time of informed consent to 6 years following surgery, self-reported adverse events were reviewed by the study physician during patient contact and follow-ups.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Botulinum Toxin Type A Injection Arm | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
In this split-person study, a total of 18 patients were analyzed. The unit of measure was each side of the head which were assigned to treatment arm or no treatment arm. Among 37 total participants enrolled, 31 received the split-person treatment, underwent surgery and had tissues collected. Tissues of 18 patients fulfilled all criteria for inclusion for transcriptome analyses and data interpretation (data quality, background thresholding and normalization).
| Age, Categorical(Participants) | Treatment With Onabotulinumtoxin A Injection | No Treatment | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 17 | 34 |
| >=65 years | 1 | 1 | 2 |
| Age, Continuous(years) | Treatment With Onabotulinumtoxin A Injection | No Treatment | Total |
|---|---|---|---|
| Mean | 45 ± 14 | 45 ± 14 | 45 ± 14 |
| Sex: Female, Male(Participants) | Treatment With Onabotulinumtoxin A Injection | No Treatment | Total |
|---|---|---|---|
| Female | 17 | 17 | 34 |
| Male | 1 | 1 | 2 |
| Race and Ethnicity Not Collected(Participants) | Treatment With Onabotulinumtoxin A Injection | No Treatment | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Treatment With Onabotulinumtoxin A Injection | No Treatment | Total |
|---|---|---|---|
| United States | 18 | 18 | 18 |
| Monthly migraine days(days per month) | Treatment With Onabotulinumtoxin A Injection | No Treatment | Total |
|---|---|---|---|
| Mean | 19 ± 10 | 19 ± 10 | 19 ± 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Aug 2023, 68 months.
Results were first posted in Mar 2025, 1 year 7 months after primary completion.
Of 49 non-industry phase 4 interventional studies under Migraine Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's 68 months is above that.
Counting every sponsor, half of 77 studies reached it within 27 months; a quarter within 17 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A
Massachusetts General Hospital →