drugset / Trial / NCT05016661
Extension Study of ABP-20001 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 for Migraine Prevention
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2021-10-19
- Primary completion
- 2024-07-31
- Completion
- 2024-08-30
Outcome
Outcome not reported
Stopped: “Study was terminated due to the analysis of the data not meeting the intended primary endpoint and key secondary endpoints.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PrabotulinumtoxinA | Protein / enzyme biologic | — | Intramuscular |