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NCT05028569 · ClinicalTrials.gov registry record · Phase 3
Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
A Phase 3 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 3
- Development phase
- 775
- Enrollment target
NCT05028569: Clinical Trial Phase 3 study, sponsored by AbbVie.
NCT05028569 is a Phase 3 study that was terminated before completion, run by AbbVie. The registered enrollment target is 775 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05028569, a Phase 3 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 775 participants
- Enrollment target
Study Summary
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (International Classification of Headache Disorders, 2018). Migraine can be further categorized according to the frequency of attacks as episodic migraine (EM) or chronic migraine (CM). This study will assess the effects of BOTOX in preventing migraine in adult participants with EM. BOTOX is being developed for the prevention of migraine in adults with episodic migraine (EM). Participants will be enrolled in 3 different treatment groups. There is 1 in 3 chance that participants will be assigned to receive placebo. Approximately 777 adult participants with EM will be enrolled in approximately 125 sites across the world. Participants will receive intramuscular injections (injected into the muscle) of BOTOX or Placebo on Day 1 and Week 12. Eligible participants will receive BOTOX on Week 24 and Week 36. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Primary Outcome
The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Interventions
- DRUG Placebo
- DRUG BOTOX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 775 participants |
| Start Date | 2021-11-05 |
| Est. Completion | 2024-11-06 |
| Phase | Phase 3 |
Why NCT05028569 stopped before completion
NCT05028569 is an interventional study that assigns participants to a tested intervention. The registered 775 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05028569 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05028569 about?
NCT05028569 is a clinical study titled "Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine". Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (International Classification of Headache Disorders, 2018). Migraine can be further categorized according to the frequency of attacks as episodic m...
What is the current status of trial NCT05028569?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 775 participants. The study started on 2021-11-05. Estimated completion is 2024-11-06.
What interventions are being tested in trial NCT05028569?
The interventions under investigation include: Placebo (DRUG), BOTOX (DRUG).
Who is sponsoring clinical trial NCT05028569?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05028569's enrollment target sits among peer trials
775 439th of 2000 higher than 1,562 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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