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NCT03381261 · ClinicalTrials.gov registry record · Phase 4
(Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT03381261: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT03381261 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 37 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03381261, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 ge
Interventions
- DRUG Botulinum toxin type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 4 |
What the finished NCT03381261 record still lists
NCT03381261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Botulinum toxin type A is the first listed.
NCT03381261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03381261 about?
NCT03381261 is a clinical study titled "(Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist". 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.
What is the current status of trial NCT03381261?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2017-12-01. Estimated completion is 2023-12-01.
What interventions are being tested in trial NCT03381261?
The interventions under investigation include: Botulinum toxin type A (DRUG).
Who is sponsoring clinical trial NCT03381261?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03381261's enrollment target sits among peer trials
37 1482nd of 2000 higher than 511 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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