The trial is taking place at:
B

Bispebjerg Hospital | Dermatologisk Afdeling

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

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Pfizer

Status and phase

Enrolling
Phase 4

Conditions

Migraine

Treatments

Drug: Rimegepant
Drug: Placebo

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

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

Trial contacts and locations

149

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Central trial contact

Pfizer Pfizer CT.gov Call Center

Data sourced from clinicaltrials.gov

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