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

Phase 4

Completed

• Conditions: Migraine
• Interventions: Drug: Rimegepant; Drug: Placebo

• Registration Number: NCT05518123
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2022-11-07
• Primary Completion: 2025-03-31
• Status Verified: 2025-07
• Study Completion: 2025-07-08
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 658

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 first 28- days of the 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rimegepant 75 mg	Rimegepant	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Compare the efficacy of rimegepant (75 mg) to placebo	Week 1 to 12 of DBT Phase	Subjects are dosed every other day, for the preventative treatment of migraine as measured by mean change in number of migraine days per month (28 days) over 12 week DBT Phase. A migraine day is any calendar day in which the subject experiences a qualified migraine headache. This includes any calendar day in which the subject takes an acute migraine-specific medication.

Trial Locations

Locations (110)

Clinical Research Institute; 🇺🇸 Los Angeles, California, United States

California Neuroscience Research, LLC; 🇺🇸 Sherman Oaks, California, United States

Ki Health Partners LLC, dba New England Institute for Clinical Research; 🇺🇸 Stamford, Connecticut, United States

Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit; 🇺🇸 Edgewater, Florida, United States

Wr-Msra,Llc; 🇺🇸 Lake City, Florida, United States

AppleMed Research Group, LLC; 🇺🇸 Miami, Florida, United States

Sensible Healthcare LLC; 🇺🇸 Ocoee, Florida, United States

Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit; 🇺🇸 Ormond Beach, Florida, United States

Boston Clinical Trials; 🇺🇸 Boston, Massachusetts, United States

Community Clinical Research Network, Inc.; 🇺🇸 Marlborough, Massachusetts, United States

Scroll for more (100 remaining)