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Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT02867709
First received: August 12, 2016
Last updated: September 6, 2017
Last verified: September 2017
  Purpose
This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.

Condition Intervention Phase
Migraine, With or Without Aura Drug: Ubrogepant Drug: Placebo-matching Ubrogepant Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants with Pain Freedom at 2 Hours after Initial Dose [ Time Frame: 2 Hours ]
  • Percentage of Participants with Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours after Initial Dose [ Time Frame: 2 Hours ]

Secondary Outcome Measures:
  • Percentage of Participants with Sustained Pain Freedom from 2 to 24 Hours after Initial Dose [ Time Frame: 2 to 24 Hours ]
  • Percentage of Participants with Pain Relief at 2 Hours after the Initial Dose [ Time Frame: 2 Hours ]
  • Percentage of Participants with Sustained Pain Relief from 2 to 24 Hours after the Initial Dose [ Time Frame: 2 to 24 Hours ]
  • Percentage of Participants with the Absence of Photophobia at 2 Hours after the Initial Dose [ Time Frame: 2 Hours ]
  • Percentage of Participants with the Absence of Phonophobia at 2 Hours after the Initial Dose [ Time Frame: 2 Hours ]
  • Percentage of Participants with Absence of Nausea at 2 Hours after the Initial Dose [ Time Frame: 2 Hours ]
  • Percentage of Participants Satisfied or Extremely Satisfied at 2 Hours after Initial Treatment using the 7-Point Satisfaction with Study Medication Scale [ Time Frame: 2 Hours ]
  • Percentage of Participants with Sustained Pain Freedom from 2 to 48 Hours after Initial Dose [ Time Frame: 2 to 48 Hours ]
  • Percentage of Participants with Sustained Pain Relief from 2 to 48 Hours after the Initial Dose [ Time Frame: 2 to 48 Hours ]
  • Percentage of Participants able to Function Normally at 2 Hours after Initial Treatment using the 4-Point Functional Disability Scale [ Time Frame: 2 Hours ]

Estimated Enrollment: 1650
Actual Study Start Date: August 26, 2016
Estimated Study Completion Date: December 14, 2017
Estimated Primary Completion Date: December 14, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ubrogepant 25 mg
1 ubrogepant 25 mg tablet orally for treatment of a qualifying migraine attack. Participants may receive a second dose or placebo-matching ubrogepant orally 2 hours after initial treatment if applicable followed by 1 ubrogepant 25 mg tablet 4 days after the qualifying migraine attack for Pharmacokinetic (PK) sampling.
Drug: Ubrogepant
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Experimental: Ubrogepant 50 mg
1 ubrogepant 50 mg tablet orally for treatment of a qualifying migraine attack. Participants may receive a second dose or placebo-matching ubrogepant orally 2 hours after initial treatment if applicable followed by 1 ubrogepant 50 mg tablet 4 days after the qualifying migraine attack for PK sampling.
Drug: Ubrogepant
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Placebo Comparator: Placebo
1 ubrogepant placebo-matching tablet orally for treatment of a qualifying migraine attack. Participants may receive a second dose orally 2 hours after initial treatment if applicable followed by 1 ubrogepant placebo-matching tablet 4 days after the qualifying migraine attack for PK sampling.
Drug: Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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 International Classification of Headache Disorders, 3rd edition, beta version
  • Migraine onset before age 50
  • History of migraines typically lasting 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 previous 3 months.

Exclusion Criteria:

  • Difficulty distinguishing migraine headache from tension-type other headaches
  • Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months
  • Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine
  • Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
  • Required hospital treatment of a migraine attack 3 or more times in the previous 6 months
  • Has a chronic non-headache pain condition requiring daily pain medication
  • Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • Has a history of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; patients with prior gastric bariatric interventions which have been reversed are not excluded
  • Has a history of hepatitis within previous 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02867709

Contacts
Contact: Clinical Trials Registry Team 1-800-347-4500 IR-CTRegistration@allergan.com

  Show 110 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Adele Thorpe Allergan
  More Information

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02867709     History of Changes
Other Study ID Numbers: UBR-MD-02
Study First Received: August 12, 2016
Last Updated: September 6, 2017

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

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 19, 2017