Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine

Episodic Migraine Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Open-label 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: NCT03700320
• Other study ID #: 3101-302-002
• Status: Completed
• Phase: Phase 3
• Start date: October 8, 2018
• Est. completion date: May 21, 2020

Study information

• Verified date: May 2021
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: May 21, 2020
• Est. primary completion date: May 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
• Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment.
• Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
• At least a 1-year history of migraine with or without aura consistent with a diagnosis
• Age of the participant at the time of migraine onset < 50 years
• History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

Exclusion Criteria:

• Difficulty distinguishing migraine headaches from tension-type or other headaches
• Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
• Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy
• = 15 headache days per month on average across the 3 months prior to Visit 1
• Usage of opioids or barbiturates > 2 days/month, triptans or ergots = 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) = 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
• 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
• Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease
• Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of mercury (mm Hg) or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once.
• At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
• History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Drug:
• Standard of Care (SOC) Migraine Preventive Medication
Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.
• Atogepant
Atogepant tablets taken orally, once daily for 52 weeks.

Locations

Country	Name	City	State
United States	Synexus Clinical Research US, Inc.	Akron	Ohio
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
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	Michigan Headache & Neurological Institute	Ann Arbor	Michigan
United States	Atlanta Center for Clinical Research	Atlanta	Georgia
United States	Synexus Clinical Research US, Inc.	Atlanta	Georgia
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Tekton Research, Inc	Austin	Texas
United States	Kentucky Pediatric Research	Bardstown	Kentucky
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Hassman Research Institutes	Berlin	New Jersey
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Clinical Research Advantage, Inc./Simon Williamson Clinic, PC	Birmingham	Alabama
United States	Northwest Clinical Trials	Boise	Idaho
United States	DiscoveResearch, Inc.	Bryan	Texas
United States	Hope Clinical Research	Canoga Park	California
United States	Synexus Clinical Research US, Inc./East Valley Family Physicians PLC	Chandler	Arizona
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	Synexus Clinical Research US, Inc.	Cincinnati	Ohio
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	Delta Waves, Inc.	Colorado Springs	Colorado
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Meridian Clinical Research, LLC	Dakota Dunes	South Dakota
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	iResearch Atlanta	Decatur	Georgia
United States	J. Lewis Research, Inc./Foothill Family Clinic Draper	Draper	Utah
United States	Pharmacology Research Institute	Encino	California
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Evanston Premier Healthcare Research LLC	Evanston	Illinois
United States	Plains Clinical Medical Clinic, LLC	Fargo	North Dakota
United States	Advanced Neurosciences Research, LLC	Fort Collins	Colorado
United States	MD Clinical	Hallandale Beach	Florida
United States	Infinity Clinical Research	Hollywood	Florida
United States	Earle Research	Houston	Texas
United States	Research Trials WorldWide, LLC	Humble	Texas
United States	Sun Valley Research Center, Inc.	Imperial	California
United States	Irvine Center for Clinical Research	Irvine	California
United States	Clinical Neuroscience Solutions	Jacksonville	Florida
United States	Synexus Clinical Research US, Inc.	Jamaica	New York
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Beyer Research	Kalamazoo	Michigan
United States	Volunteer Research Group	Knoxville	Tennessee
United States	Grossmont Center for Clinical Research	La Mesa	California
United States	Altea Research Institute	Las Vegas	Nevada
United States	Synergy San Diego	Lemon Grove	California
United States	MidAmerica Neuroscience Research Foundation dba Rowe Neurology Institute	Lenexa	Kansas
United States	Collaborative Neuroscience Network, LLC.	Long Beach	California
United States	Pharmacology Research Institute	Los Alamitos	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	SSM Dean Health Research	Madison	Wisconsin
United States	Meridien Research	Maitland	Florida
United States	Central New York Clinical Research	Manlius	New York
United States	Community Clinical Research Network	Marlborough	Massachusetts
United States	Suburban Research Associates	Media	Pennsylvania
United States	CNS Healthcare - Memphis	Memphis	Tennessee
United States	Advanced Clinical Research	Meridian	Idaho
United States	Synexus Clinical Research US, Inc./Desert Clinical Research, LLC	Mesa	Arizona
United States	Well Pharma Medical Research, Corp.	Miami	Florida
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	Pacific Research Partners, LLC	Oakland	California
United States	Excell Research, Inc.	Oceanside	California
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	Olive Branch Family Medical Center	Olive Branch	Mississippi
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	Quality Clinical Research	Omaha	Nebraska
United States	Synexus Clinical Research US, Inc	Omaha	Nebraska
United States	Bioclinica Research	Orlando	Florida
United States	Clinical Neuroscience Solutions, Inc	Orlando	Florida
United States	Kansas Institute of Research	Overland Park	Kansas
United States	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Synexus Clinical Research US, Inc./Central Phoenix Medical Clinic, LLC	Phoenix	Arizona
United States	Summit Research Network	Portland	Oregon
United States	Phoenix Medical Research, Inc.	Prairie Village	Kansas
United States	Amici Clinical Research	Raritan	New Jersey
United States	Desert Valley Research	Redlands	California
United States	Rochester Clinical Research	Rochester	New York
United States	Oregon Center for Clinical Investigations, Inc.	Salem	Oregon
United States	Synexus Clinical Research US, Inc.	San Antonio	Texas
United States	California Research Foundation	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California
United States	Artemis Institute for Clinical Research	San Marcos	California
United States	California Medical Clinic for Headache	Santa Monica	California
United States	Frontier Clinical Research, LLC	Scottdale	Pennsylvania
United States	Seattle Women's: Health, Research	Seattle	Washington
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	Encompass Clinical Research	Spring Valley	California
United States	ClinVest	Springfield	Missouri
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Infinity Clinical Research LLC	Sunrise	Florida
United States	Meridien Research	Tampa	Florida
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Trinity Clinical Research	Tullahoma	Tennessee
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Synexus Clinical Research US, Inc.	Vista	California
United States	Diablo Clinical Research, Inc	Walnut Creek	California
United States	ClinPoint Trials	Waxahachie	Texas
United States	Advanced Clinical Research	West Jordan	Utah
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Premiere Research Institute	West Palm Beach	Florida
United States	Upstate Clinical Research Associates, LLC	Williamsville	New York
United States	Ohio Clinical Research, LLC	Willoughby Hills	Ohio

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 (TEAE)	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any 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. A TEAE is an AE that occurs or worsens after receiving investigational study drug.	From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Secondary	Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator	Laboratory tests included tests of hematology, chemistry, and urinalysis. The investigator determined if the results were potentially clinically significant (PCS). Only categories with at least one participant are reported.	From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Secondary	Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator	A standard 12-lead ECG was performed. The investigator determined if the result was potentially clinically significant. Only categories with at least one participant are reported.	Up to Week 52
Secondary	Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator	Vital sign measurements included sitting and standing blood pressure (BP), sitting and standing pulse rate, respiratory rate, temperature, and body weight. The investigator determined if the results were clinically significant. Only categories with at least one participant are reported.	From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up)
Secondary	Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior	The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was 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. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior). Only the most severe suicidal ideation and the most severe suicidal behavior counted during the treatment period for at least 1 participant are reported.	Up to Week 52