Clinical trial for Migraine
Official title Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
ClinicalTrials.gov ID: NCT06417775
What this study is testing
What is Ubrogepant?
Ubrogepant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for migraine.
Also referred to as UBRELVY.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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.
You likely can't join if
- 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...
- Acute headache medication overuse.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Canoga Park, California, United States
- Colton, California, United States
- Fresno, California, United States
- Glendale, California, United States
- Imperial, California, United States
- Irvine, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Stamford, Connecticut, United States
- Boca Raton, Florida, United States
+ 77 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Huntsville, Alabama, United States; Chandler, Arizona, United States; Gilbert, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States and 91 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.