NCT05198245Fut, nem toboroz
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
RETROSPECTIVE COHORT STUDY OF PREGNANCY OUTCOMES IN WOMEN EXPOSED TO RIMEGEPANT DURING PREGNANCY
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 29.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 1 (tervezett)
- Első benyújtás
- 2021. dec. 15.
- Kezdés
- 2021. dec. 15.
- Elsődleges befejezés
- 2028. ápr. 17.
- Fő szponzor
- Pfizer
- Betegségek
- Migrén
- NCT-szám
- NCT05198245
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 1
- 2021. dec. 15. és az elsődleges befejezés (2028. ápr. 17.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Has at least 1 pharmacy dispensing for CGRP monoclonal antibodies (i.e., erenumab, fremanezumab, eptinezumab, and galcanezumab) within a 5-half-life time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period
- Additional Eligibility Criteria (Rimegepant-Exposed Group):
- Have at least 1 pharmacy dispensing for a medication indicated for the treatment of migraine within the 30-day time window before the estimated LMP and ending with whichever is first: end of pregnancy or end of the study period.
Egyéb
- Has insufficient information to estimate LMP
- Has at least 1 pharmacy dispensing for ditans (i.e., lasmiditan) within a 5-half-life time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period
- Has at least 1 pharmacy dispensing for a CGRP receptor antagonist other than rimegepant (i.e., ubrogepant, atogepant, and zavegepant) within a 5-half-life time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period
- Have a migraine diagnosis any time before the estimated LMP and through whichever is first: end of pregnancy or end of the study period
- Have at least 1 pharmacy dispensing for rimegepant within the 30-day time window before the estimated LMP and through whichever is first: end of pregnancy or end of the study period
- Have a recorded outcome of pregnancy within the study period
- Had continuous enrollment in a health care plan with medical and pharmacy benefits during the 6-month period before the estimated LMP through a postpartum period of 42 days
- Additional Inclusion Criteria (Primary Comparator Group):
- Have a migraine diagnosis any time before the estimated LMP and through whichever is first: end of pregnancy or end of the study period
- Have a recorded outcome of pregnancy within the study period
- Had continuous enrollment in a health care plan with medical and pharmacy benefits during the 6-month period before the estimated LMP through a postpartum period of 42 days
- Additional Exclusion Criteria (Primary Comparator Group):
- Have at least 1 pharmacy dispensing for rimegepant within the 30-day time window before the estimated LMP and through whichever is first: end of pregnancy or end of the study period
- Additional Inclusion Criteria (Secondary Comparator Group):
- Have no migraine diagnosis any time before the estimated LMP through whichever is first: end of pregnancy or end of the study period
- Have a recorded outcome of pregnancy within the study period
- Had continuous enrollment in a health care plan with medical and pharmacy benefits during the 6-month period before the estimated LMP through a postpartum period of 42 days
- Additional Exclusion Criteria (Secondary Comparator Group):
- Have at least 1 pharmacy dispensing for rimegepant within the 30-day time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period
Kiket keres a vizsgálat
- All pregnant women aged 16 to 49 years, inclusive, at the estimated LMP within the study observation period are eligible to enter in the study.
Életkor a regiszterben: 16 év – 49 év · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Pfizer | New York | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.