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

Migraine, With or Without Aura Clinical Trial

— ACHIEVE I  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828020
• Other study ID #: UBR-MD-01
• Status: Completed
• Phase: Phase 3
• Start date: July 22, 2016
• Est. completion date: December 14, 2017

Study information

• Verified date: December 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1672
• Est. completion date: December 14, 2017
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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 any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded

• Has a history of hepatitis within previous 6 months.

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine, With or Without Aura

Intervention

Drug:
• Ubrogepant
50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
• Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	Michigan Head-Pain & Neurological Institute	Ann Arbor	Michigan
United States	Midtown Neurology	Atlanta	Georgia
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Tekton Research, Inc.	Austin	Texas
United States	Pharmasite Research, Inc.	Baltimore	Maryland
United States	Kentucky Pediatric/Adult Research	Bardstown	Kentucky
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Alpine Clinical Research Center, Inc.	Boulder	Colorado
United States	Neuro-Behavioral Clinical Research, Inc.	Canton	Ohio
United States	The Research Center of Southern California, LLC	Carlsbad	California
United States	Med Center	Carmichael	California
United States	WR-ClinSearch, LLC	Chattanooga	Tennessee
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Colorado Springs Neurological Associates	Colorado Springs	Colorado
United States	Delta Waves, Inc	Colorado Springs	Colorado
United States	Aventiv Research, Inc	Columbus	Ohio
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Associated Neurologists, P.C.	Danbury	Connecticut
United States	Denver Neurological Research	Denver	Colorado
United States	J. Lewis Research, Inc. / Foothill Family Clinic Draper	Draper	Utah
United States	T. Joseph Raoof MD, Inc./Encino Research Center	Encino	California
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Associated Neurolgists of Southern Connecticut, PC	Fairfield	Connecticut
United States	Neurology Center of North Orange County	Fullerton	California
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Behavioral Research Specialists, LLC	Glendale	California
United States	CPI MD Clinical	Hallandale Beach	Florida
United States	Neurology Associates, P.A.	Hickory	North Carolina
United States	Infinity Clinical Research, LLC	Hollywood	Florida
United States	Principals Research Group, Inc.	Hot Springs	Arkansas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Beyer Research	Kalamazoo	Michigan
United States	Holston Medical Group	Kingsport	Tennessee
United States	Prime Care Clinical Research	Laguna Hills	California
United States	Red Star Research, LLC	Lake Jackson	Texas
United States	Clinical Research Advantage, Inc./Diagnostic Center of Medicine - Durango	Las Vegas	Nevada
United States	Rowe Neurology Institute	Lenexa	Kansas
United States	BTC of Lincoln	Lincoln	Rhode Island
United States	KLR Business Group, Inc. dba Arkansas Clinical Research	Little Rock	Arkansas
United States	Collaborative Neuroscience Network, LLC.	Long Beach	California
United States	Ohio Clinical Research, LLC	Lyndhurst	Ohio
United States	Central New York Clinical Research	Manlius	New York
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Clinical Research Advantage, Inc./Desert Clinical Research, LLC.	Mesa	Arizona
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Synergy San Diego	National City	California
United States	Deaconess Clinic, Medical Office Building 1 Research Institute	Newburgh	Indiana
United States	Newport Beach Clinical Research Associates, Inc.	Newport Beach	California
United States	North County Clinical Research	Oceanside	California
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	MPH IPS Research Company	Oklahoma City	Oklahoma
United States	NPC Research	Oklahoma City	Oklahoma
United States	Olive Branch Family Medical Center	Olive Branch	Mississippi
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	College Park Family Care Center Physicians Group - Neurology Research Department	Overland Park	Kansas
United States	Kansas Institute of Research	Overland Park	Kansas
United States	Palm Beach Neurological Center/Advanced Research Consultants, Inc.	Palm Beach Gardens	Florida
United States	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Xenoscience, Inc.	Phoenix	Arizona
United States	Oregon Center For Clinical Investigations Inc. (OCCI, Inc.)	Portland	Oregon
United States	Summit Research Network	Portland	Oregon
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Granger Medical Clinic-Riverton	Riverton	Utah
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Highland Clinical Research	Salt Lake City	Utah
United States	Optimum Clinical Research, Inc.	Salt Lake City	Utah
United States	Clinical Trials Texas, Inc	San Antonio	Texas
United States	Road Runner Research, Ltd.	San Antonio	Texas
United States	Medical Center for Clinical Research	San Diego	California
United States	CA Medical Clinic for Headache	Santa Monica	California
United States	The Polyclinic Madison Center	Seattle	Washington
United States	Southern California Research LLC	Simi Valley	California
United States	Northeast Medical Research Associates, Inc	South Dartmouth	Massachusetts
United States	Meridien Research	Spring Hill	Florida
United States	Encompass Clinical Research	Spring Valley	California
United States	Clinvest Research, LLC	Springfield	Missouri
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Meridien Research	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Clinical Research Advantage, Inc./Orange Grove Family Practice	Tucson	Arizona
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	MedVadis Research Corporation	Watertown	Massachusetts
United States	Neurology Research Institute	West Palm Beach	Florida
United States	PMG Research of Winston-Salem, LLC.	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose	Pain freedom was defined as a reduction in headache severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.	Baseline (Predose) to 2 hours after initial dose
Primary	Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose	The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms.	Baseline (Predose) to 2 hours after initial dose
Secondary	Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose	Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.	Baseline (Predose) to 2 hours after initial dose
Secondary	Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose	Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain relief from 2 to 24 hours after initial dose.	2 to 24 hours after initial dose
Secondary	Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose	Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain freedom from 2 to 24 hours after initial dose.	2 to 24 hours after initial dose
Secondary	Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose	Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.	2 hours after initial dose
Secondary	Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose	Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.	2 hours after initial dose
Secondary	Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose	Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.	2 hours after initial dose

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