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

AbbVie

Status and phase: Enrolling; Phase 3

Conditions: Migraine

Treatments: Drug: Ubrogepant; Drug: Placebo for Ubrogepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06417775

M23-714

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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450 participants in 3 patient groups

Double-Blind Period: Ubrogepant

Experimental group

Description:

Participants will receive ubrogepant during the double-blind period.

Treatment:

Drug: Ubrogepant

Double-Blind Period: Placebo for Ubrogepant

Experimental group

Description:

Participants will receive placebo during the double-blind period.

Treatment:

Drug: Placebo for Ubrogepant

Open-Label Extension Period: Ubrogepant

Experimental group

Description:

Eligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period.

Treatment:

Drug: Ubrogepant