Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine - Trial NCT06417775

Timeline & Enrollment

Primary Outcome

Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Period (PMP),Number of Participants With Adverse Events (AEs)

Summary

A migraine is a moderate to severe headache typically on one side of the head. A migraine
 attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to
 light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks
 that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The
 PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will
 assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events
 and change in disease activity will be assessed.
 
 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).
 
 There may be higher treatment burden for participants in this trial compared to their
 standard of care. Participants will collect data daily in electronic diaries and attend
 regular visits during the study at a hospital or clinic. The effect of the treatment will be
 checked by medical assessments, blood tests, checking for side effects and completing
 questionnaires.

ICD-10 Classifications