Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants (PRODROME)

• ClinicalTrials.gov Identifier: NCT04492020
• Recruitment Status: Recruiting
• First Posted: July 30, 2020
• Last Update Posted: January 6, 2021
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Tracking Information

• First Submitted Date: July 27, 2020
• First Posted Date: July 30, 2020
• Last Update Posted Date: January 6, 2021
• Actual Study Start Date: August 21, 2020
• Estimated Primary Completion Date: March 2, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 27, 2020)

Percentage of participants reporting absence of headache of moderate/severe intensity within 24 hours post-dose [ Time Frame: 24 hours after taking double-blind study intervention during the prodrome ]

The absence of a headache of moderate/severe intensity will be recorded by the participant in an eDiary within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 27, 2020)

• Percentage of participants reporting absence of headache of any intensity within 24 hours post-dose [ Time Frame: 24 hours after taking double-blind study intervention during the prodrome ]
  The absence of a headache of any intensity will be recorded by the participant in an eDiary within 24 hours after taking double-blind study intervention during the prodrome in order to determine the prevention of the headache
• Percentage of participants reporting absence of headache of moderate or severe intensity within 48 hours post-dose [ Time Frame: 48 hours after taking doubleblind study intervention during the prodrome ]
  The absence of a headache of moderate or severe intensity will be recorded by the participant in an eDiary within 48 hours after taking doubleblind study intervention during the prodrome in order to determine the prevention of headache
• Percentage of participants reporting improvement in the ability to function normally within 24 hours post-dose [ Time Frame: 24 hours after taking double-blind study intervention during the prodrome ]
  The Functional Disability Scale (FDS) is a single item used to measure the participant's level to function normally. Participants will be asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary) within 24 hours after taking double-blind study intervention during the prodrome

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
• Official Title: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
• Brief Summary: Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Migraine

Intervention

• Drug: Ubrogepant 100mg
  For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
• Drug: Placebo
  For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours

Study Arms

• Experimental: Treatment Sequence A
  Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event
  Interventions:

  • Drug: Ubrogepant 100mg
  • Drug: Placebo
• Experimental: Treatment Sequence B
  Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event
  Interventions:

  • Drug: Ubrogepant 100mg
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 27, 2020): 600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2, 2022
• Estimated Primary Completion Date: March 2, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3 (International Classification of Headache Disorders 3rd edition)
• Migraine onset before age 50 years
• By history, the participant'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 in each of the 3 months prior to the Screening Visit

Exclusion Criteria:

• Difficulty distinguishing migraine headache from tension-type or other headaches
• Participants who overuse medication for migraine defined as use of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment
• Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3
• A current diagnosis of chronic migraine as defined by ICHD-3 or a history of 15 or more headache days per month on average in the 6 months prior to Visit 1 in the investigator's judgment. A headache day is defined as a day in which there was any occurrence of a headache of a minimum duration of 2 hours or a headache of any duration for which acute medication was taken.
• Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
• Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to Visit 1.
• History of malignancy in the 5 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
• History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that, per investigator judgment, may affect the absorption or metabolism of the study intervention; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Clinical Trial Registry Team; 877-277-8566; IR-CTRegistration@allergan.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04492020
• Other Study ID Numbers: 3110-304-002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Allergan
• Study Sponsor: Allergan
• Collaborators: Not Provided

Investigators

• Study Director: Joel Trugman; Allergan

• PRS Account: Allergan
• Verification Date: January 2021