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NCT05016661 · ClinicalTrials.gov registry record · Phase 2
Extension Study of ABP-20001 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 for Migraine Prevention
A Phase 2 study, sponsored by AEON Biopharma.
- Terminated
- Registry status
- Phase 2
- Development phase
- 466
- Enrollment target
NCT05016661: Clinical Trial Phase 2 study, sponsored by AEON Biopharma.
NCT05016661 is a Phase 2 study that was terminated before completion, run by AEON Biopharma. The registered enrollment target is 466 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (250% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05016661, a Phase 2 study, was terminated before completion, sponsored by AEON Biopharma.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 466 participants
- Enrollment target
Study Summary
This Phase 2 Extension trial will evaluate the efficacy and safety of ABP-450 for migraine prevention in adults who suffer from six or more migraine days per month. The study will enroll approximately 666 patients across approximately 65 sites in the United States, Canada and Australia from the Phase 2 trial. Study subjects will be divided evenly across a low dose group and a high dose group. All patients will receive four treatment cycles of ABP-450 utilizing the Company's novel injection paradigm.
Primary Outcome
The primary safety endpoint will be the incidence of TEAEs throughout the study when dosed with ABP-450 (low dose) or ABP-450 (high dose).
Interventions
- DRUG ABP-450
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 466 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2024-08-30 |
| Phase | Phase 2 |
Why NCT05016661 stopped before completion
NCT05016661 is an interventional study that assigns participants to a tested intervention. The registered 466 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (250% higher).
The record links to 0 conditions, and to 1 intervention - of which ABP-450 is the first listed.
NCT05016661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05016661 about?
NCT05016661 is a clinical study titled "Extension Study of ABP-20001 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 for Migraine Prevention". This Phase 2 Extension trial will evaluate the efficacy and safety of ABP-450 for migraine prevention in adults who suffer from six or more migraine days per month. The study will enroll approximately 666 patients across approximately 65 sites in the United States, Canada and Australia from the Phas...
What is the current status of trial NCT05016661?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 466 participants. The study started on 2021-10-19. Estimated completion is 2024-08-30.
What interventions are being tested in trial NCT05016661?
The interventions under investigation include: ABP-450 (DRUG).
Who is sponsoring clinical trial NCT05016661?
This trial is sponsored by AEON Biopharma, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05016661's enrollment target sits among peer trials
466 80th of 2000 higher than 1,921 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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