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

Migraine Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417775
• Other study ID #: M23-714
• Status: Recruiting
• Phase: Phase 3
• Start date: May 23, 2024
• Est. completion date: September 8, 2027

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 8, 2027
• Est. primary completion date: September 3, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Ubrogepant
Oral Tablets
• Placebo for Ubrogepant
Oral Tablets

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials, Inc. /ID# 257212	Albuquerque	New Mexico
United States	Headlands PharmaSite /ID# 257208	Baltimore	Maryland
United States	Neurology Offices of South Florida, PLLC /ID# 257161	Boca Raton	Florida
United States	Charlottesville Medical Research /ID# 257154	Charlottesville	Virginia
United States	Centricity Research Columbus /ID# 257221	Columbus	Ohio
United States	Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403	DeLand	Florida
United States	Lillestol Research, LLC /ID# 257896	Fargo	North Dakota
United States	Neuro Pain Medical Center /ID# 257155	Fresno	California
United States	IMA Clinical Research Westchester /ID# 259157	Hartsdale	New York
United States	Alliance for Multispeciality Research - Knoxville /ID# 257846	Knoxville	Tennessee
United States	Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874	Lakeland	Florida
United States	Los Angeles Headache Center /ID# 257237	Los Angeles	California
United States	BTC of New Bedford /ID# 257128	New Bedford	Massachusetts
United States	Alliance for Multispecialty Research LLC /ID# 257839	Newton	Kansas
United States	Sensible Healthcare /ID# 257198	Ocoee	Florida
United States	Lynn Institute of Oklahoma City /ID# 257857	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc /ID# 257190	Orlando	Florida
United States	Clinical Research of Philadelphia, LLC /ID# 257197	Philadelphia	Pennsylvania
United States	WR - Medical Center for Clinical Research /ID# 257897	San Diego	California
United States	Clinvest Research LLC /ID# 257215	Springfield	Missouri
United States	Clinical Research Atlanta - Headlands LLC /ID# 260181	Stockbridge	Georgia
United States	Puget Sound Neurology /ID# 257174	Tacoma	Washington
United States	Synexus Clinical Research US, Inc. - Tucson /ID# 258309	Tucson	Arizona
United States	Alliance for Multispeciality Research - Wichita East /ID# 257148	Wichita	Kansas
United States	Conquest Research /ID# 258314	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Period (PMP)	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.	Up to approximately 16 Weeks
Primary	Number of Participants With Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to approximately 68 Weeks
Secondary	Change From Baseline in Number of Headache Days Occurring During Perimenstrual Period (PMP)	A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.	Up to approximately 16 Weeks
Secondary	Change From Baseline in Number of Moderate or Severe Headache Days During Perimenstrual Period (PMP)	A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.	Up to approximately 16 Weeks
Secondary	Change From Baseline in Number of Migraine Days With Moderate or Severe Headache During Perimenstrual Period (PMP)	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.	Up to approximately 16 Weeks
Secondary	Percentage of Participants With No Disability/ Mild Impairment for most (>= 65%) of PMP Days	Functional Disability Scale (FDS) is a single item used to measure the participant's level of functional disability. Participants will be asked to rate the performance of daily activities in the past 24 hours using 4 response options ranging from "No disability, able to function normally" to "Severely impaired, cannot do all or most things, bed rest may be necessary."	Up to approximately 16 Weeks
Secondary	Change From Baseline in Acute Medication Use Days During the Perimenstrual Period (PMP)	An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.	Up to approximately 16 Weeks
Secondary	Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days During the Perimenstrual Period (PMP)	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.	Up to approximately 16 Weeks
Secondary	Percentage of Participants Achieving "Not at all limited" or "A little limited" Daily Activity Level for Most (>= 65%) of PMP Days	Activity Level is a single-item used to assess overall limitations with performing daily activities over 24 hours with a 5-level response ranging from "Not at all limited" to "Unable to do daily activities."	Up to approximately 16 Weeks

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