An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

Migraine, With or Without Aura Clinical Trial

Official title:

A Multicenter, Randomized, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873221
• Other study ID #: UBR-MD-04
• Status: Completed
• Phase: Phase 3
• Start date: September 13, 2016
• Est. completion date: August 2, 2018

Study information

• Verified date: August 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.

Description:

Usual care is the open-label control arm. Dose of ubrogepant (50 mg or 100 mg) will be double-blind for active treatment arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1254
• Est. completion date: August 2, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

Inclusion Criteria:

-Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).

Exclusion Criteria:

• Patients with clinically significant electrocardiogram (ECG), vital sign, physical exam, or laboratory abnormalities

• Requirement for a medication during the study that is on the list of prohibited medications.

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
Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.
• Usual Care
Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.

Locations

Country	Name	City	State
United States	Radiant Research, Inc.	Akron	Ohio
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	DENT Neurosciences Research Center	Amherst	New York
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Radiant Research	Anderson	South Carolina
United States	Michigan Head Pain & Neurological Institute	Ann Arbor	Michigan
United States	Axiom Research	Apple Valley	California
United States	Midtown Neurology	Atlanta	Georgia
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	Future Search Trials	Austin	Texas
United States	Tekton Research	Austin	Texas
United States	Aventura Neurological Associates, PA	Aventura	Florida
United States	Pharma Site Research	Baltimore	Maryland
United States	Seton Medical Group	Baltimore	Maryland
United States	Kentucky Pediatric Research Inc	Bardstown	Kentucky
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Radiant Research, Inc.	Birmingham	Alabama
United States	Boston Clinical Trials Inc	Boston	Massachusetts
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Hope Clinical Research	Canoga Park	California
United States	Neuro-Behavioral Clinical Research, Inc	Canton	Ohio
United States	Med Center Medical Clinic Carmichael	Carmichael	California
United States	East Family Physicians PC/Radiant Research, Inc.	Chandler	Arizona
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	Clinsearch, LLC	Chattanooga	Tennessee
United States	Cedar Crosse Research Center	Chicago	Illinois
United States	Great Lakes Clinical Trials, LLC	Chicago	Illinois
United States	Michigan Ave. Internists /Radiant Research, Inc.	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	CTI Clinical research Center	Cincinnati	Ohio
United States	Patient Priority Clinical Sites	Cincinnati	Ohio
United States	Radiant Research, Inc	Cincinnati	Ohio
United States	Sentral Clinical Research Services	Cincinnati	Ohio
United States	University of cincinnati	Cincinnati	Ohio
United States	Ohio Clinical Research, LLC	Cleveland	Ohio
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	Clinicos LLC	Colorado Springs	Colorado
United States	Colorado Springs Neurological Associates	Colorado Springs	Colorado
United States	Delta Waves, Inc	Colorado Springs	Colorado
United States	Axiom Research, LLC	Colton	California
United States	Vista Clinical Research	Columbia	South Carolina
United States	Aventiv Research Inc.	Columbus	Ohio
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Clinical Research South Florida	Coral Gables	Florida
United States	Futuresearch Trials of Dallas, LP	Dallas	Texas
United States	Radiant Research, Inc.	Dallas	Texas
United States	Texas Neurology, P.A.	Dallas	Texas
United States	Associated Neurologists, PC	Danbury	Connecticut
United States	Avail Clinical Research	DeLand	Florida
United States	Denver Neurological Research	Denver	Colorado
United States	J. Lewis Research, Inc. / Foothill Family Clinic Draper	Draper	Utah
United States	Encino Research Center/T Joseph Raoof MD Inc	Encino	California
United States	Pharmacology Research Institute	Encino	California
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Summit Headache and Neurologic Institute	Englewood	Colorado
United States	Deaconess Clinic Inc.	Evansville	Indiana
United States	Associated Neurologists of Southern Connecticut, PC	Fairfield	Connecticut
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	Fort Collins	Colorado
United States	Prairie Fields Family Medicine	Fremont	Nebraska
United States	California Headache and Balance Center	Fresno	California
United States	Neuro-Pain Medical Center, Inc	Fresno	California
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	The Minneapolis Clinic of Neurology, Ltd.	Golden Valley	Minnesota
United States	Headache Wellness Center	Greensboro	North Carolina
United States	Wilks & Safirstein MD PA D/B/A MD Clinical	Hallandale Beach	Florida
United States	Neurology Associates, P.A.	Hickory	North Carolina
United States	Broward Research	Hollywood	Florida
United States	Infinity Clinical Research	Hollywood	Florida
United States	Principals Research Group, Inc.	Hot Springs	Arkansas
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	Clinical Neuroscience Solutions Inc	Jacksonville	Florida
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Women's Health Care Specialists	Kalamazoo	Michigan
United States	Holston Medical Group, P.C.	Kingsport	Tennessee
United States	New Orleans Center for Clinical Research	Knoxville	Tennessee
United States	Grossmont Center For Clinical Research	La Mesa	California
United States	Red Star Research, LLC	Lake Jackson	Texas
United States	Diagnostic Center of Medicine - Durango / Radiant Research, Inc.	Las Vegas	Nevada
United States	Rowe Neurology Institute	Lenexa	Kansas
United States	Lincoln Research	Lincoln	Rhode Island
United States	Arkansas Clinical Research	Little Rock	Arkansas
United States	Collaborative Neuroscience Network, LLC	Long Beach	California
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Pacific Institute of Medical Research	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Norton Neurology Services	Louisville	Kentucky
United States	Neurology Associates, P.A.	Maitland	Florida
United States	Central New York Clinical Research	Manlius	New York
United States	CNS Healthcare	Memphis	Tennessee
United States	Advanced Clinical Research	Meridian	Idaho
United States	Desert Clinical Research /Radiant Research, Inc.	Mesa	Arizona
United States	LCC Medical Research	Miami	Florida
United States	Well Pharma Medical Research	Miami	Florida
United States	Panax Clinical Research	Miami Lakes	Florida
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Lake Shore Clinical Research, LLC	Mooresville	North Carolina
United States	West Virginia University	Morgantown	West Virginia
United States	Synergy San Diego	National City	California
United States	BTC of New Bedford	New Bedford	Massachusetts
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Newport Beach Clinical Research Associates, Inc.	Newport Beach	California
United States	Pharmacology Research Institute	Newport Beach	California
United States	Clinical Research Associates Tidewater	Norfolk	Virginia
United States	Northeast Medical Research Associates, Inc.	North Dartmouth	Massachusetts
United States	Renstar Medical Research	Ocala	Florida
United States	Sensible Healthcare, LLC	Ocoee	Florida
United States	Advanced Research Institute	Ogden	Utah
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	NPC Research	Oklahoma City	Oklahoma
United States	Sooner Clinical Research Inc	Oklahoma City	Oklahoma
United States	Olive Branch Family Medical Center	Olive Branch	Mississippi
United States	Clinical Research Advantage, Inc/Synexus USA	Omaha	Nebraska
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc - Memphis, TN	Orlando	Florida
United States	College Park Family Care Center Physicians Group- Neurology Research Dept	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 Philadelphia	Philadelphia	Pennsylvania
United States	Central Phoenix Medical Clinic	Phoenix	Arizona
United States	Xenoscience, Inc.	Phoenix	Arizona
United States	Preferred Primary Care Physicians, Inc.	Pittsburgh	Pennsylvania
United States	Oregon Center For Clinical Investigations Inc	Portland	Oregon
United States	Summit Research Network Inc.	Portland	Oregon
United States	Princeton Medical Institute	Princeton	New Jersey
United States	Beacon Clinical Research, LLC	Quincy	Massachusetts
United States	Wake Research Associates LLC	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	Granger Medical Clinic - Riverton	Riverton	Utah
United States	Robbins Headache Clinic	Riverwoods	Illinois
United States	Blue Ridge Research Center	Roanoke	Virginia
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Highland Clinical Reserach	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	San Antonio	Texas
United States	Artemis Institute For Clinical Research	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California
United States	California Medical Clinic for Headache	Santa Monica	California
United States	The Polyclinic	Seattle	Washington
United States	Southern California Research Center	Simi Valley	California
United States	Hillcrest Clinical Research LLC	Simpsonville	South Carolina
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	Qps Mra, Llc	South Miami	Florida
United States	Meridien Research	Spring Hill	Florida
United States	Encompass Clinical Research	Spring Valley	California
United States	Clinvest	Springfield	Missouri
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	South Puget Sound Neurology	Tacoma	Washington
United States	Meridien Research	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Orange Grove Family Practice/Radiant Research, Inc.	Tucson	Arizona
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	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Radiant Research	Vista	California
United States	Medvadis Research Corporation	Watertown	Massachusetts
United States	Neurology Research Institute Palm Beach	West Palm Beach	Florida
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina
United States	New England Regional Headache Center	Worcester	Massachusetts

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 at Least 1 Treatment Emergent Adverse Event	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.	56 Weeks
Secondary	Number of Participants With Clinically Significant Laboratory Values	Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.	56 Weeks
Secondary	Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings	ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.	56 Weeks
Secondary	Number of Participants With Clinically Significant Vital Sign Measurements	Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.	56 Weeks
Secondary	Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales	On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"	56 Weeks

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