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

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

Brief Summary:
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome

Condition or disease Intervention/treatment Phase
Migraine Drug: Ubrogepant 100mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 21, 2020
Estimated Primary Completion Date : March 2, 2022
Estimated Study Completion Date : March 2, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine
Drug Information available for: Ubrogepant

Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492020


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

Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Joel Trugman Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04492020    
Other Study ID Numbers: 3110-304-002
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allergan:
Migraine
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases