A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine

Conditions

• Acute Treatment of Migraine

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rimegepant — DRUG
  Rimegepant

Study Details

Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack. International Headache Society (IHS) global practice recommendations for the Acute Treatment of Migraine suggest a second dose of the same medication within the recommended dose limit in people with headache relapse after successful initial treatment of a migraine attack. The primary purpose of this study is to evaluate the safety and tolerability of redosing of rimegepant when taken for the acute treatment of a migraine attack, as it is possible that some patients may benefit from a second dose of rimegepant in this setting.

Key Dates

Start date

May 28, 2026

Status verified

Jun 2026

Primary completion

May 15, 2028

Completion

May 15, 2028

Study Design

Enrollment

400 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rimegepant
  Participants will receive rimegepant 75 mg ODT to administer for the acute treatment of migraine attacks of moderate or severe headache pain intensity. A second rimegepant 75 mg ODT should be taken in the event that participants are not pain free at approximately 2 hours post initial dose OR upon headache relapse after initial pain freedom. The second dose should be taken within 24 hours of the initial dose. Participants will receive rimegepant over a 24 week period during the OLT phase. Participants may redose with rimegepant up to a maximum of 10 times per month (28 days) during the OLT phase.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs), serious TEAEs, and TEAEs leading to study intervention discontinuation on treatment by average monthly redosing frequency over the entire OLT phase (<3, ≥3 to <6, ≥6 re-doses per month) and overall [ Time Frame: Up to 6 months ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (3)

Find similar trials in Canoga Park, CA

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