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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 is a Phase 3 study that was terminated before completion, run by AbbVie. The registered enrollment target is 775 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05028569
The ClinicalTrials.gov registry entry for NCT05028569 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 775 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05028569 reports 0 study locations.
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.
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