New Study Call-In information

Protocol # UBR-MD-02

Title:  A MULTICENTER, RANDOMIZED, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF ORAL UBROGEPANT IN THE ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA

Coordinator: Guido Elias

Type of Volunteer:  Adults with ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA

Length of Study:  60  days

Specific Inclusions: 

• Migraine onset before age 50
• By history, the patient’s migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
• History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the 3 months prior to Screening (Visit 1)

Specific Exclusions: 

• Difficulty distinguishing migraine headache from tension-type or other headaches.
• History of 15 or more headache days per month on average in the 6 months prior to Visit 1 in the investigator’s judgment, or a current diagnosis of chronic migraine as defined by ICHD-3 beta
• Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3 beta
• Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to Visit 1.
• Hypertension as defined by sitting systolic blood pressure > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg at Visits 1 or 2. Vital sign measurements that exceed these limits may be repeated only once..