Phase 2
Completed N=885
Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
Migraine · Acute Treatment of Migraine
Source: ClinicalTrials.gov NCT01430442 ↗
Enrolled (actual)
885
Serious AEs
0.4%
Results posted
Sep 2020
Primary outcomePrimary: Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose — 14; 12; 27; 28 Participants
Summary
The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711) compared with placebo in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point numeric rating scale (no pain, mild pain, moderate pain, severe pain) while identifying an optimal dose to support the Phase 3 clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose |
14; 12; 27; 28; 33; 20 | — |
| SECONDARY Number of Participants With Total Migraine Freedom at 2 Hours Post Dose |
13; 11; 24; 22; 26; 16 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events |
15; 10; 18; 12; 18; 14 | — |
| SECONDARY Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose |
9; 10; 24; 24; 29; 17 | — |
| SECONDARY Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose |
8; 9; 24; 24; 29; 17 | — |
Eligibility Criteria
Key Inclusion Criteria
- Patient with at least 1-year history of migraines (with or without aura) including the following:
- Migraine attacks more than 1 year with age of onset prior to 50 years of age
- Migraine attacks, on average, last about 4 - 72 hours if untreated
- No more than 8 attacks of moderate to severe intensity per month within last 3 months
- Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months
- Less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening
- Male and female ≥ 18 years and ≤ age 65
- No clinically significant abnormality identified on the medical or laboratory evaluation
Key Exclusion Criteria
- Patient has a history of basilar migraine or hemiplegic migraine
- Patient does not receive migraine relief from triptan migraine treatment
- Medications that may alter the pH of the stomach (acid reducing agents), such as H-2 antagonists, Proton Pump inhibitors (PPI), antacids
- History of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months
- History of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months
Data sourced from ClinicalTrials.gov (NCT01430442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.