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NCT01516892 · ClinicalTrials.gov registry record · Phase 4
A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
A Phase 4 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 4
- Development phase
- 716
- Enrollment target
NCT01516892: Completed Phase 4 study, sponsored by Allergan.
NCT01516892 is a Phase 4 study that has completed, run by Allergan. The registered enrollment target is 716 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01516892, a Phase 4 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 716 participants
- Enrollment target
Study Summary
This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine.
Primary Outcome
Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.
Interventions
- BIOLOGICAL onabotulinumtoxinA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 716 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-11 |
| Phase | Phase 4 |
What the finished NCT01516892 record still lists
NCT01516892 is an interventional study that assigns participants to a tested intervention. The registered 716 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 1 intervention - of which onabotulinumtoxinA is the first listed.
NCT01516892 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01516892 about?
NCT01516892 is a clinical study titled "A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine". This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine.
What is the current status of trial NCT01516892?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 716 participants. The study started on 2011-12. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01516892?
The interventions under investigation include: onabotulinumtoxinA (BIOLOGICAL).
Who is sponsoring clinical trial NCT01516892?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01516892's enrollment target sits among peer trials
716 114th of 2000 higher than 1,887 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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