AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06641466Tipo: INTERVENTIONALInicio: 11 de mar de 2025Fin estimado: 30 de mar de 2027

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 45 YearsSexo: FEMALE

Criterios de inclusión

Participant has regular menstrual cycles ≥24 days and ≤34 days
A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition
A history of menstrual migraine attacks of at least 3 months
Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening.
If the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the Screening visit and, the dose is not expected to change during the course of the study

Criterios de exclusión

Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to Screening
History of retinal migraine, basilar migraine or hemiplegic migraine
Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
Other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea

Intervenciones

drug

Rimegepant

Rimegepant 75 mg ODT for 7 days

drug

Placebo Comparator

Matching placebo oral disintegrating tablets for 7 days

drug

Standard of Care

Standard of care for acute treatment as needed

drug

Rimegepant

Rimegepant 75 mg ODT for acute treatment as needed

Ubicaciones

IDIM - Instituto de Investigaciones Metabólicas

Ciudad de Buenos Aires, Buenos Aires, Argentina

RECRUITING

Mautalen Salud e Investigación

Buenos Aires, Buenos Aires F.D., Argentina

RECRUITING

Sanatorio del Sur

San Miguel de Tucumán, Tucumán Province, Argentina

RECRUITING

Patrocinadores

PrincipalPfizer

Contactos

Pfizer CT.gov Call Center

CONTACT

ClinicalTrials.gov_Inquiries@pfizer.com 1-800-718-1021

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