Placeholder Chronic Knee Pain to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
TITLE:
Placeholder Chronic Knee Pain found by Richard McClintock, a philologist, director of publications at Hampden-Sydney College in Virginia; he searched for citings of consectetur in classical Latin literature, a term of remarkably low frequency in that literary corpus.
MEDICAL CONTION:
Chronic Knee Pain
AGE:
18+
SEX/GENDER:
Female
Overview
Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 450 adult female participants with menstrual migraine will be enrolled in approximately 85 sites in the United States and Puerto Rico.
Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks).
Study Details
Inclusion Criteria:
- At least a 1-year history of migraine with or without aura.
- Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period.
- Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis.
- Have regular menstrual cycles of between 21-35 days in length.
- Less than 15 headache days per month.
- At least 70% compliance completing screening period and at least 4 out of 5 days of ediary data in each of 3 screening PMP.
Exclusion Criteria:
- History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine.
- Clinically significant history of cardiovascular or cerebrovascular disease per the investigator’s opinion.
- Clinically significant abnormalities in the physical examination as determined by the investigator.
- Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator’s opinion.
- Acute headache medication overuse.