Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

Pfizer

Status and phase: Completed; Phase 2

Conditions: Acute Treatment of Migraine; Migraine

Treatments: Drug: Rimegepant; Drug: Placebo; Drug: Sumatriptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01430442

CN170-003

Details and patient eligibility

About

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.

Full description

Intervention Model: Parallel Versus Comparator + Placebo

Enrollment: 1,026 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,026 participants in 8 patient groups, including a placebo group

Treatment A: Rimegepant, 10 mg

Experimental group

Description:

Participants received a single dose (one capsule) of rimegepant 10 milligram (mg) orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.

Treatment:

Drug: Placebo

Drug: Rimegepant

Treatment B: Rimegepant, 25 mg

Experimental group

Description:

Participants received a single dose (one capsule) of rimegepant 25 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.

Treatment:

Drug: Placebo

Drug: Rimegepant

Treatment C: Rimegepant, 75 mg

Experimental group

Description:

Participants received a single dose (one capsule) of rimegepant 75 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.

Treatment:

Drug: Placebo

Drug: Rimegepant

Treatment D: Rimegepant, 150 mg

Experimental group

Description:

Participants received a single dose (one capsule) of rimegepant 150 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.

Treatment:

Drug: Placebo

Drug: Rimegepant

Treatment E: Rimegepant, 300 mg

Experimental group

Description:

Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.

Treatment:

Drug: Placebo

Drug: Rimegepant

Treatment F: Rimegepant, 600 mg

Experimental group

Description:

Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.

Treatment:

Drug: Placebo

Drug: Rimegepant

Treatment P: Rimegepant Placebo-Matching Capsules

Placebo Comparator group

Description:

Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.

Treatment:

Drug: Placebo

Treatment G: Sumatriptan 100 mg

Active Comparator group

Description:

Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three rimegepant matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.

Treatment:

Drug: Sumatriptan

Drug: Placebo