Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine

Episodic Migraine Clinical Trial

Official title:

A Phase 3, Multicenter, Open-Label 40-week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939312
• Other study ID #: 3101-309-002
• Status: Completed
• Phase: Phase 3
• Start date: May 6, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2022
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once a day for the prevention of migraine in participants with episodic migraine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 685
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Written informed consent and participant privacy information (eg, written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.

• Participants must be using a medically acceptable and effective method of birth control during the course of the entire study.

• Eligible participants who completed the double-blind treatment period (Visit 7) and the follow-up period (Visit 8), if applicable, depending on the timing of study initiation, of Study 3101-301-002 (NCT03777059) without significant protocol deviations (eg, noncompliance to protocol-required procedures).

Exclusion Criteria:

• Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1.

• Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Visit 1.

• Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant
Atogepant Tablets

Locations

Country	Name	City	State
United States	Synexus Clinical Research US, Inc.	Akron	Ohio
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	PMG Research, Inc. d/b/a PMG Research of McFarland Clinic	Ames	Iowa
United States	Dent Neurosciences Research Center	Amherst	New York
United States	Primary Care Associates/Synexus Clinical	Anderson	South Carolina
United States	Neurotrials Research	Atlanta	Georgia
United States	Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology	Atlanta	Georgia
United States	Synexus Clinical Research, Inc	Atlanta	Georgia
United States	Psychiatry & Psychotherapy Partners Austin	Austin	Texas
United States	Tekton Research	Austin	Texas
United States	Aventura Neurological Associates	Aventura	Florida
United States	Pharmasite Research, Inc.	Baltimore	Maryland
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Neurology Offices of South Florida	Boca Raton	Florida
United States	John R. Graham Headache Center Brigham and Women's Faulkner Hospital	Boston	Massachusetts
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Med Center Medical Clinic	Carmichael	California
United States	Synexus Clinical Research US, Inc.	Chandler	Arizona
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	PMG Research of Charlotte, LLC	Charlotte	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	ClinSearch	Chattanooga	Tennessee
United States	Diamond Headache Clinic Ltd	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Patient Priority Clinical Sites	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Colorado Springs Neurological Associates	Colorado Springs	Colorado
United States	Aventiv Research Inc	Columbus	Ohio
United States	Partners in Clinical Research, LLC	Cumberland	Rhode Island
United States	Synexus-US	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	OK Clinical Research, LLC	Edmond	Oklahoma
United States	Colorado Neurological Institute	Englewood	Colorado
United States	Eastside Therapeutic Resource and Core Clinical Research	Everett	Washington
United States	Ventavia Research Group	Fort Worth	Texas
United States	California Headache and Balance Center	Fresno	California
United States	Neuro Pain Medical Center	Fresno	California
United States	Sarkis Clinical Trials- Gainesville	Gainesville	Florida
United States	Principals Research Group	Hot Springs	Arkansas
United States	Centex Studies, Inc.	Houston	Texas
United States	Protenium Clinical Research	Hurst	Texas
United States	JWM Neurology	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Westside Center for Clinical Research	Jacksonville	Florida
United States	Holston Medical Group	Kingsport	Tennessee
United States	Grossmont Center for Clinical Research	La Mesa	California
United States	Paradigm Clinical Research Centers, Inc	La Mesa	California
United States	Ocean State Clinical Research Partners	Lincoln	Rhode Island
United States	Arkansas Clinical Research	Little Rock	Arkansas
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Torrance Clinical Research Institute, Inc.	Lomita	California
United States	Long Beach Clinical Trials Services	Long Beach	California
United States	Ohio Clinical Research, LLC	Lyndhurst	Ohio
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Well Pharma Medical Research, Corp	Miami	Florida
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	BTC of New Bedford	New Bedford	Massachusetts
United States	DelRicht Research	New Orleans	Louisiana
United States	Deaconess Clinic - Gateway Health Center	Newburgh	Indiana
United States	Newport Beach Clinical Research Associates	Newport Beach	California
United States	Pharmacology Research Institute	Newport Beach	California
United States	Health Research of Hampton Roads	Newport News	Virginia
United States	Heartland Research Associates, LLC	Newton	Kansas
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Excell Research, Inc.	Oceanside	California
United States	Synexus Clinical Research US, Inc.	Omaha	Nebraska
United States	Clinical Neuroscience Solutions	Orlando	Florida
United States	Neurology Associates of Ormond Beach	Ormond Beach	Florida
United States	College Park Family Care Center	Overland Park	Kansas
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Alea Research	Phoenix	Arizona
United States	Central Phoenix Medical Clinic	Phoenix	Arizona
United States	Preferred Primary Care Physicians	Pittsburgh	Pennsylvania
United States	Collective Medical Research	Prairie Village	Kansas
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	Raleigh Neurology Associates, P.A.	Raleigh	North Carolina
United States	Rancho Cucamonga Clinical Trials	Rancho Cucamonga	California
United States	Desert Valley Research	Redlands	California
United States	George J. Rederich, M.D. Inc.	Redondo Beach	California
United States	National Clinical Research, Inc	Richmond	Virginia
United States	The Headache Center	Ridgeland	Mississippi
United States	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	Highland Clinical Research	Salt Lake City	Utah
United States	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah
United States	Synexus-US	Salt Lake City	Utah
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Synexus Clinical Research, Inc	San Antonio	Texas
United States	Optimus Medical Group	San Francisco	California
United States	Sarasota Memorial Hospital Clinical Research Center	Sarasota	Florida
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	California Neuroscience Research	Sherman Oaks	California
United States	Hillcrest Family Practice	Simpsonville	South Carolina
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	J. Lewis Research, Inc.	South Jordan	Utah
United States	Clinvest Research LLC	Springfield	Missouri
United States	New England Institute for Clinical Research	Stamford	Connecticut
United States	Puget Sound Neurology	Tacoma	Washington
United States	Axiom Clinical Research of Florida	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	Tucson	Arizona
United States	Tulsa Clinical Research	Tulsa	Oklahoma
United States	Preferred Primary Care Physicians, Jacob Murphy	Uniontown	Pennsylvania
United States	Sentara Neruology Specialists	Virginia Beach	Virginia
United States	ClinPoint Trials	Waxahachie	Texas
United States	Heartland Research Associates, LLC - An AMR Company	Wichita	Kansas
United States	Heartland Research Associates, LLC - An AMR Company	Wichita	Kansas
United States	Abington Neurological Associates	Willow Grove	Pennsylvania
United States	Wilmington Health, PLLC	Wilmington	North Carolina
United States	Piedmont Medical Research of Winston-Salem	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 at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.	From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Secondary	Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator	Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. Percentage of participants with PCS laboratory values are summarized for chemistry, hematology, and urinalysis. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during post-baseline are reported.	Up to Week 44
Secondary	Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator	12-lead ECGs were performed at select study visits. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.	Up to Week 40
Secondary	Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator	PCS postbaseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting and standing], pulse rate [sitting and standing], respiratory rate, temperature, weight. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.	Up to Week 44
Secondary	Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS)	C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior.	OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44

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