Clinical Trial Details

Overview

Research Study Summary

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

Purpose
This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.
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CW ID: 222886
Date Last Changed: February 2, 2017

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 to 75 Years
Overall Status
Recruiting
Lead Sponsor
Allergan
Facility Type
N/A

Eligibility

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 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 gastric or small intestinal surgery, or has a disease that causes malabsorption
  • Has a history of hepatitis within previous 6 months.

Contact

Sherry Harlan
University of South Florida - Morsani Center for Advanced Healthcare
13330 USF Laurel Dr
Tampa, FL 33612
Phone: (813) 396-0768

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