Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Part of paid clinical trials in New York, New York.

Sponsor
Pfizer
Study ID
NCT05198245
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Rimegepant — DRUG
    Rimegepant 75mg
  • Various — DRUG
    Various
  • No intervention — OTHER
    No intervention

Study Details

The purpose of the study is to evaluate the risk of pregnancy and infant outcomes among women with migraine exposed to rimegepant during pregnancy and in two rimegepant unexposed comparator groups.

Key Dates

Start date
Dec 15, 2021
Status verified
Jan 2026
Primary completion
Apr 17, 2028
Completion
Apr 17, 2028

Study Design

Enrollment
1 participants (estimated)

Arms

  • Arm: Pregnancies in women with migraine and exposure to rimegepant
  • Arm: Pregnancies in women with migraine exposed to other medications
    Pregnancies in women with migraine exposed to other medications indicated for the treatment of migraine
  • Arm: Pregnancies in women without migraine

Primary Outcome Measure

Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births [ Time Frame: Annually beginning April 2022 ]

Locations (1)

FacilityCityStateZIPSite coordinators
PfizerNew YorkNew York10001-

Find similar trials in New York, NY

By condition
Migraine
By specialty
Neurology
By research site
Pfizer· New York, NY

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