Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
- Conditions
- Episodic Migraine
- Interventions
- Drug: Standard of Care (SOC) Migraine Preventive Medication
- Registration Number
- NCT03700320
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 744
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral SOC Migraine Preventive Medication Standard of Care (SOC) Migraine Preventive Medication Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant. Atogepant 60 mg Atogepant Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up 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.
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator Up to Week 52 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.
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) 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.
Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior Up to Week 52 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.
Trial Locations
- Locations (101)
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Well Pharma Medical Research, Corp.
🇺🇸Miami, Florida, United States
Seattle Women's: Health, Research
🇺🇸Seattle, Washington, United States
Clinical Research Advantage, Inc./Simon Williamson Clinic, PC
🇺🇸Birmingham, Alabama, United States
Synexus Clinical Research US, Inc.
🇺🇸San Antonio, Texas, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Summit Research Network
🇺🇸Portland, Oregon, United States
Synexus Clinical Research US, Inc
🇺🇸Omaha, Nebraska, United States
Research Trials WorldWide, LLC
🇺🇸Humble, Texas, United States
Pharmacology Research Institute
🇺🇸Los Alamitos, California, United States
Grossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Sun Valley Research Center, Inc.
🇺🇸Imperial, California, United States
Synexus Clinical Research US, Inc./Central Phoenix Medical Clinic, LLC
🇺🇸Phoenix, Arizona, United States
Pacific Research Partners, LLC
🇺🇸Oakland, California, United States
California Research Foundation
🇺🇸San Diego, California, United States
Delta Waves, Inc.
🇺🇸Colorado Springs, Colorado, United States
Desert Valley Research
🇺🇸Redlands, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
California Medical Clinic for Headache
🇺🇸Santa Monica, California, United States
Diablo Clinical Research, Inc
🇺🇸Walnut Creek, California, United States
Clinical Neuroscience Solutions
🇺🇸Jacksonville, Florida, United States
Infinity Clinical Research
🇺🇸Hollywood, Florida, United States
Advanced Neurosciences Research, LLC
🇺🇸Fort Collins, Colorado, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Infinity Clinical Research LLC
🇺🇸Sunrise, Florida, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
Kentucky Pediatric Research
🇺🇸Bardstown, Kentucky, United States
MidAmerica Neuroscience Research Foundation dba Rowe Neurology Institute
🇺🇸Lenexa, Kansas, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Clinical Research Institute, Inc.
🇺🇸Minneapolis, Minnesota, United States
Regional Clinical Research, Inc.
🇺🇸Endwell, New York, United States
Evanston Premier Healthcare Research LLC
🇺🇸Evanston, Illinois, United States
Altea Research Institute
🇺🇸Las Vegas, Nevada, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Community Clinical Research Network
🇺🇸Marlborough, Massachusetts, United States
Princeton Center for Clinical Research
🇺🇸Skillman, New Jersey, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Dent Neurosciences Research Center
🇺🇸Amherst, New York, United States
CNS Healthcare - Memphis
🇺🇸Memphis, Tennessee, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Upstate Clinical Research Associates, LLC
🇺🇸Williamsville, New York, United States
Plains Clinical Medical Clinic, LLC
🇺🇸Fargo, North Dakota, United States
Ohio Clinical Research, LLC
🇺🇸Willoughby Hills, Ohio, United States
Frontier Clinical Research, LLC
🇺🇸Smithfield, Pennsylvania, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
J. Lewis Research, Inc./Foothill Family Clinic Draper
🇺🇸Draper, Utah, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Phoenix Medical Research, Inc.
🇺🇸Prairie Village, Kansas, United States
Rochester Clinical Research
🇺🇸Rochester, New York, United States
Central New York Clinical Research
🇺🇸Manlius, New York, United States
Synexus Clinical Research US, Inc./Desert Clinical Research, LLC
🇺🇸Mesa, Arizona, United States
Clinical Research of Philadelphia, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research Associates of Tidewater
🇺🇸Norfolk, Virginia, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Atlanta Center for Clinical Research
🇺🇸Atlanta, Georgia, United States
Beyer Research
🇺🇸Kalamazoo, Michigan, United States
DiscoveResearch, Inc.
🇺🇸Bryan, Texas, United States
ClinVest
🇺🇸Springfield, Missouri, United States
Meridian Clinical Research, LLC
🇺🇸Dakota Dunes, South Dakota, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Synexus Clinical Research US, Inc./East Valley Family Physicians PLC
🇺🇸Chandler, Arizona, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
Irvine Center for Clinical Research
🇺🇸Irvine, California, United States
Collaborative Neuroscience Network, LLC.
🇺🇸Long Beach, California, United States
Artemis Institute for Clinical Research
🇺🇸San Marcos, California, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Sensible Healthcare LLC
🇺🇸Ocoee, Florida, United States
Kansas Institute of Research
🇺🇸Overland Park, Kansas, United States
Hassman Research Institutes
🇺🇸Berlin, New Jersey, United States
Amici Clinical Research
🇺🇸Raritan, New Jersey, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Oregon Center for Clinical Investigations, Inc.
🇺🇸Salem, Oregon, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Radiant Research, Inc.
🇺🇸Anderson, South Carolina, United States
Trinity Clinical Research
🇺🇸Tullahoma, Tennessee, United States
Earle Research
🇺🇸Houston, Texas, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Charlottesville Medical Research Center, LLC
🇺🇸Charlottesville, Virginia, United States
ClinPoint Trials
🇺🇸Waxahachie, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
SSM Dean Health Research
🇺🇸Madison, Wisconsin, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Orlando, Florida, United States
Bioclinica Research
🇺🇸Orlando, Florida, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Michigan Headache & Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
Tekton Research, Inc
🇺🇸Austin, Texas, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Excell Research, Inc.
🇺🇸Oceanside, California, United States