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

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ClinicalTrials.gov Identifier: NCT02867709
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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 or disease Intervention/treatment Phase
Migraine, With or Without Aura Drug: Ubrogepant Drug: Placebo-matching Ubrogepant Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1686 participants
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
Actual Study Start Date : August 26, 2016
Actual Primary Completion Date : February 26, 2018
Actual Study Completion Date : February 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Percentage of Participants with Pain Freedom at 2 Hours after Initial Dose [ Time Frame: 2 Hours ]
  2. 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 :
  1. Percentage of Participants with Sustained Pain Freedom from 2 to 24 Hours after Initial Dose [ Time Frame: 2 to 24 Hours ]
  2. Percentage of Participants with Pain Relief at 2 Hours after the Initial Dose [ Time Frame: 2 Hours ]
  3. Percentage of Participants with Sustained Pain Relief from 2 to 24 Hours after the Initial Dose [ Time Frame: 2 to 24 Hours ]
  4. Percentage of Participants with the Absence of Photophobia at 2 Hours after the Initial Dose [ Time Frame: 2 Hours ]
  5. Percentage of Participants with the Absence of Phonophobia at 2 Hours after the Initial Dose [ Time Frame: 2 Hours ]
  6. Percentage of Participants with Absence of Nausea at 2 Hours after the Initial Dose [ Time Frame: 2 Hours ]


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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 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.

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): NCT02867709


  Show 108 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Adele Thorpe Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02867709     History of Changes
Other Study ID Numbers: UBR-MD-02
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

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