Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies
- Conditions
- Headache, Migraine
- Registration Number
- NCT05503082
- Lead Sponsor
- Chicago Headache Center & Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Male or female patients ages 18 to 75 years, at screening (Visit 1).<br><br> - At least a 1-year history of migraine with or without aura.<br><br> - History of =3 monthly headache days of at least moderate severity.<br><br> - Study patient currently on CGRPmAbs must be on treatment > 1 month at screening.<br><br> - By history, the patient's migraines typically last between 4 and 72 hours if<br> untreated or treated unsuccessfully and migraine episodes are separated by at least<br> 48 hours of headache pain freedom<br><br>Exclusion Criteria:<br><br> - History of <3 monthly headache days of at least moderate severity<br><br> - Concomitant use of strong CYP3A4 inducers (e.g., phenytoin, barbiturates, rifampin,<br> St. John's Wort)<br><br> - Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole,<br> clarithromycin)<br><br> - Currently on Botox treatment for CM.<br><br> - Concomitant use of gepants as a preventative treatment.<br><br> - Current user of illicit drugs, or a history within 1 year prior to screening (visit<br> 1) of drug or alcohol abuse or dependence<br><br> - Clinically significant hematologic, endocrine, cardiovascular, pulmonary,<br> gastrointestinal, or neurologic disease. If there is a history of such a disease,<br> but the condition has been stable for more than 1 year prior to screening (visit 1)<br> and is judged by the PI as not likely to interfere with participation in the study,<br> the participant may be included.<br><br> - Woman is pregnant, planning to become pregnant during the course of the study, or<br> currently lactating.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain freedom;Freedom from most bothersome symptom
- Secondary Outcome Measures
Name Time Method Pain relief at 2 hours;Percentage of patients with sustained pain relief from 2-24 hours after initial dose.;Percentage of patients with sustained pain freedom from 2-24 hours after initial dose.;Pain relief at 2 hours after 2nd dose;Percentage of patients with sustained pain relief from 2-24 hours after 2nd dose.;Percentage of patients with sustained pain freedom from 2-24 hours after 2nd dose.