Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications

Pfizer

Status and phase: Enrolling; Phase 4

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Rimegepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05518123

BHV3000-407

C4951012 (Other Identifier)

2022-001176-34 (EudraCT Number)

Details and patient eligibility

About

This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
2. Migraine attacks, on average, lasting about 4 - 72 hours, if untreated.
3. 4 to 14 migraine days per month, on average, across the 3 months prior to the Screening Visit (month is defined as 28-days for the purpose of this protocol).
4. Less than15 headache days (migraine or non-migraine) per month in each of the 3-months prior to the Screening Visit and throughout the Screening Phase.
5. Subjects must be able to distinguish migraine attacks from tension/cluster headaches. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered, migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication).

Exclusion criteria

1. History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
2. Current medication overuse headaches.
3. 15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the 28- day Observation Phase.
4. Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across > 4 categories of recognized, orally administered, migraine-preventive medications.
5. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS]).
6. Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Rimegepant 75 mg

Experimental group

Treatment:

Drug: Rimegepant

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo