Migraine
Conditions
Keywords
Migraine, Menstrual Migraine, Ubrogepant, UBRELVY
Brief 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 496 adult female participants with menstrual migraine will be enrolled in approximately 100 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.
Interventions
DRUGUbrogepant
Oral Tablets
DRUGPlacebo for Ubrogepant
Oral Tablets
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 3 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period | Up to approximately 16 Weeks | A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary. |
| Number of Participants With Adverse Events (AEs) | Up to approximately 68 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Number of Headache Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period | Up to approximately 16 Weeks | 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. |
| Change From Baseline in Number of Moderate or Severe Headache Days During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period | Up to approximately 16 Weeks | 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. |
| Change From Baseline in Number of Migraine Days With Moderate or Severe Headache During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period | Up to approximately 16 Weeks | A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary. |
| Percentage of Participants With No Disability/ Mild Impairment for most (>= 65%) of PMP Days | Up to approximately 16 Weeks | 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." |
| Change From Baseline in Acute Medication Use Days During the Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period | Up to approximately 16 Weeks | 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. |
| Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days During the Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period | Up to approximately 16 Weeks | A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary. |
| Percentage of Participants Achieving "Not at all limited" or "A little limited" Daily Activity Level for Most (>= 65%) of PMP Days | Up to approximately 16 Weeks | 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." |
Countries
Puerto Rico, United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed