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

Migraine, With or Without Aura Clinical Trial

— ACHIEVE II  

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: NCT02867709
• Other study ID #: UBR-MD-02
• Status: Completed
• Phase: Phase 3
• Start date: August 26, 2016
• Est. completion date: February 26, 2018

Study information

• Verified date: March 2019
• 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 (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1686
• Est. completion date: February 26, 2018
• Est. primary completion date: January 25, 2018
• 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 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, diarrhoea 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
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	Radiant Research, Inc.	Akron	Ohio
United States	DENT Neurosciences Research Center	Amherst	New York
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Radiant Research, Inc.	Anderson	South Carolina
United States	Axiom Research, LLC	Apple Valley	California
United States	NeuroTrials Research, Inc.	Atlanta	Georgia
United States	The Kaufmann Clinic, Inc.	Atlanta	Georgia
United States	Aventura Neurological Associates	Aventura	Florida
United States	Overlea Personal Physicians	Baltimore	Maryland
United States	Seton Medical Group	Baltimore	Maryland
United States	Clinical Research Advantage, Inc./Simon Williamson Clinic	Birmingham	Alabama
United States	Hope Clinical Research	Canoga Park	California
United States	Clinical Research Advantage, Inc./East Valley Family Physicians, PLC	Chandler	Arizona
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	Cedar Crosse Research Center	Chicago	Illinois
United States	Clinical Research Advantage, Inc./Michigan Avenue Internists	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Patient Priority Clinical Sites, LLC	Cincinnati	Ohio
United States	Sentral Clinical Research Services	Cincinnati	Ohio
United States	University of Cincinnati Dept of Psychiatry & Behavioral Neuroscience	Cincinnati	Ohio
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Clinicos, LLC	Colorado Springs	Colorado
United States	Axiom Research, LLC	Colton	California
United States	Vista Clinical Research	Columbia	South Carolina
United States	Clinical Research South Florida	Coral Gables	Florida
United States	Radiant Research, Inc	Dallas	Texas
United States	Texas Neurology, P.A.	Dallas	Texas
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Carolina Headache Institute	Durham	North Carolina
United States	Pharmacology Research Institute	Encino	California
United States	Colorado Neurological Institute	Englewood	Colorado
United States	Plains Clinical Research Center, LLC	Fargo	North Dakota
United States	Quest Research Institute	Farmington Hills	Michigan
United States	Middle Tennessee Clinical Research	Fayetteville	Tennessee
United States	Advanced Neurosciences Research, LLC	Fort Collins	Colorado
United States	Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC	Fremont	Nebraska
United States	California Headache and Balance Center	Fresno	California
United States	Neuro-Pain Medical Center	Fresno	California
United States	Minneapolis Clinic of Neurology	Golden Valley	Minnesota
United States	Cushing Neuroscience Institute North Shore-LIJ Medical Group	Great Neck	New York
United States	Headache Wellness Center, PC	Greensboro	North Carolina
United States	Broward Research Group	Hollywood	Florida
United States	Research Trials Worldwide, LLC	Humble	Texas
United States	Sun Valley Research Center	Imperial	California
United States	Josephson Wallack Munshower Neurology P.C.	Indianapolis	Indiana
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Volunteer Research Group	Knoxville	Tennessee
United States	Grossmont Center For Clinical Research	La Mesa	California
United States	Hope Research Institute	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Pharmacology Research Institute	Los Alamitos	California
United States	California Advanced Neurotherapeutic, Inc.	Los Angeles	California
United States	Cedars Sinai Pain Center	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Norton Neurology Services MS Services	Louisville	Kentucky
United States	Neurology Associates, P.A.	Maitland	Florida
United States	iNeuro Headache Specialist	McLean	Virginia
United States	Baptist Memorial Medical Group (Neurology Specialist - Headache Clinic)	Memphis	Tennessee
United States	Advanced Clinical Research	Meridian	Idaho
United States	LCC Medical Research Institute, LLC	Miami	Florida
United States	Well Pharma Medical Research, Corp.	Miami	Florida
United States	Panax Clinical Research	Miami Lakes	Florida
United States	Medical College of Wisconsin, Department of Neurology	Milwaukee	Wisconsin
United States	Lake Shore Clinical Research, LLC	Mooresville	North Carolina
United States	West Virginia University, Department of Neurology	Morgantown	West Virginia
United States	BTC of New Bedford	New Bedford	Massachusetts
United States	Suncoast Clinical Research	New Port Richey	Florida
United States	Pharmacology Research Institute	Newport Beach	California
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Renstar Medical Research	Ocala	Florida
United States	Sensible Healthcare, LLC	Ocoee	Florida
United States	Advanced Research Institute	Ogden	Utah
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	Clinical Research Advantage, Inc	Omaha	Nebraska
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	Clinical Research Advantage, Inc./Central Phoenix Medical Clinic, LLC	Phoenix	Arizona
United States	St. Joseph's Hospital & Medical Center - Barrow Neurologic Institute (BNI)	Phoenix	Arizona
United States	Preferred Primary Care Physicians, Inc.	Pittsburgh	Pennsylvania
United States	ProHealth Care Associates, LLP	Plainview	New York
United States	Princeton Medical Institute	Princeton	New Jersey
United States	Beacon Clinical Research, LLC	Quincy	Massachusetts
United States	Raleigh Neurology Associates, PA	Raleigh	North Carolina
United States	Rancho Cucamonga Clinical Research	Rancho Cucamonga	California
United States	Desert Valley Research	Rancho Mirage	California
United States	George J Rederich MD, Inc	Redondo Beach	California
United States	The Headache Center	Ridgeland	Mississippi
United States	Robbins Headache Clinic	Riverwoods	Illinois
United States	Blue Ridge Research Center, LLC	Roanoke	Virginia
United States	Artemis Institute For Clinical Research	San Diego	California
United States	Mayo Clinic Arizona, May Clinic Scottsdale	Scottsdale	Arizona
United States	Summit Research Network Seattle, LLC	Seattle	Washington
United States	Hillcrest Clinical Research, LLC	Simpsonville	South Carolina
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	QPS MRA, LLC (Miami Research Associates)	South Miami	Florida
United States	South Puget Sound Neurology	Tacoma	Washington
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Radiant Research Inc.	Tucson	Arizona
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Sentara Neurology Specialists	Virginia Beach	Virginia
United States	Clinical Research Advantage, Inc./Cassidy Medical Group-Vista	Vista	California
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Radiant Clinical Research	Washington	District of Columbia
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Upstate Clinical Research Associates, LLC	Williamsville	New York
United States	Abington Neurological Associates, Ltd.	Willow Grove	Pennsylvania
United States	New England Regional Headache Center, Inc.	Worcester	Massachusetts
United States	Westchester Neuro. Const	Yonkers	New York

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 pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with 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 assessed.	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 assessment of 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 assessment of 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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