A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
Part of paid clinical trials in Gilbert, Arizona.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT05127486
- Phase
- PHASE4
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Galcanezumab — DRUGAdministered SC.
- Rimegepant — DRUGAdministered orally.
- Placebo — DRUGAdministered orally.
- Placebo — DRUGAdministered SC.
Study Details
The purpose of this study is to assess whether galcanezumab is superior to rimegepant in the prevention of migraine in participants with episodic migraine. The study duration will be approximately 6 months.
Key Dates
- Start date
- Dec 6, 2021
- Status verified
- Jun 2024
- Primary completion
- May 23, 2023
- Completion
- May 23, 2023
Study Design
- Enrollment
- 580 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: GalcanezumabParticipants received a loading dose of 2 injections of 120 milligrams (mg) galcanezumab subcutaneously (SC) in the first month followed by 120 mg monthly for remaining 2 months. 1 placebo oral disintegrating tablet (ODT) every other day for 3 months was given to preserve blinding.
- Active Comparator: RimegepantParticipants received 75 mg Rimegepant oral disintegrating tablet (ODT) every other day for 3 months. 2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
Primary Outcome Measure
Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period. [ Time Frame: Baseline, Month 1 through Month 3 ]
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