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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03700320
Recruitment Status : Active, not recruiting
First Posted : October 9, 2018
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
Safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year

Condition or disease Intervention/treatment Phase
Episodic Migraine Drug: Atogepant 60 mg Drug: Standard of Care (SOC) Migraine Prevention Medication Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : June 22, 2020
Estimated Study Completion Date : November 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: Atogepant 60 mg
Taken once daily
Drug: Atogepant 60 mg
Tablets containing atogepant 60 mg

Active Comparator: Oral SOC migraine prevention medication
Taken once daily
Drug: Standard of Care (SOC) Migraine Prevention Medication
Medication recognized as safe and effective for the prevention of migraine




Primary Outcome Measures :
  1. Percentage of Participants with at Least 1 Treatment Emergent Adverse Event [ Time Frame: Across the 52-week treatment period ]

Secondary Outcome Measures :
  1. Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator [ Time Frame: Across the 52-week treatment period ]
  2. Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator [ Time Frame: Across the 52-week treatment period ]
  3. Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator [ Time Frame: Across the 52-week treatment period ]
  4. Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales [ Time Frame: Across the 52-week treatment period ]

    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.

    (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior)




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC (Standard of Care) migraine prevention medications and the participant is willing to accept SOC (Standard of Care) 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 CM, new persistent daily headache, trigeminal autonomic cephalgia (eg, 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 (eg, aspirin, 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, GI, or neurologic disease
  • Hypertension as defined by sitting systolic BP > 160 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 (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700320


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Locations
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United States, Alabama
Simon Williamson Clinic
Birmingham, Alabama, United States, 35211
Achieve Clinical Research, LLC
Birmingham, Alabama, United States, 35216
United States, Arizona
East Valley Family Physicians
Chandler, Arizona, United States, 85224
Desert Clinical Research
Mesa, Arizona, United States, 85213
Central Phoenix Medical Clinic
Phoenix, Arizona, United States, 85020
United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Hope Clinical Reseach
Canoga Park, California, United States, 91303
Pharmacology Research Institute
Encino, California, United States, 91316
Sun Valley Research Center
Imperial, California, United States, 92251
Irvine Center for Clinical Research
Irvine, California, United States, 92618
Grossmont Center for Clinical Research
La Mesa, California, United States, 91942
Synergy Clinical Research Centers
Lemon Grove, California, United States, 91945
Southland Neurologic
Long Beach, California, United States, 90808
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pacific Research Partners
Oakland, California, United States, 94607
Excell Research, Inc.
Oceanside, California, United States, 92056
Desert Valley Research
Rancho Mirage, California, United States, 92270
Medical Center for Clinical Research
San Diego, California, United States, 92108
California Research Foundation
San Diego, California, United States, 92123-1881
Artemis Institute for Clinical Research
San Marcos, California, United States, 92078
California Medical Clinic for Headache
Santa Monica, California, United States, 90404
Encompass Clinical Research
Spring Valley, California, United States, 91978
Cassidy Medical Group
Vista, California, United States, 92083
Diablo Clinical Research, Inc
Walnut Creek, California, United States, 94598
United States, Colorado
Delta Waves Sleep Disorders And Research Center
Colorado Springs, Colorado, United States, 80918
Advanced Neurology of Colorado
Fort Collins, Colorado, United States, 80528
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States, 33009
Infinity Clinical Research
Hollywood, Florida, United States, 33024
Clinical Neuroscience Solutions
Jacksonville, Florida, United States, 32256
Health Awareness, Inc.
Jupiter, Florida, United States, 33458
Well Pharma Medical Research, Corp.
Miami, Florida, United States, 33143
Sensible Healthcare
Ocoee, Florida, United States, 34761
Clinical Neuroscience Solutions
Orlando, Florida, United States, 23801
Compass Research dba Bioclinica Research
Orlando, Florida, United States, 32806
Aspire Health Partners
Orlando, Florida, United States, 32810
Infinity Clinical Research
Sunrise, Florida, United States, 33351
Meridien Research
Tampa, Florida, United States, 33634
Palm Beach Medical Group
West Palm Beach, Florida, United States, 33407
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
Radiant Research - Atlanta
Atlanta, Georgia, United States, 30328
Atlanta Center for Clinical Research
Atlanta, Georgia, United States, 30331
Columbus Regional Research Institute
Columbus, Georgia, United States, 31904
iResearch Atlanta
Decatur, Georgia, United States, 30030
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Idaho
Northwest Clinical Trials
Boise, Idaho, United States, 83704
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, Illinois
Evanston Premier Healthcare Research LLC
Evanston, Illinois, United States, 60201
United States, Kansas
Rowe Neurology Institute
Lenexa, Kansas, United States, 66214
Kansas City Bone & Joint Clinic
Overland Park, Kansas, United States, 66211
Phoenix Medical Research
Prairie Village, Kansas, United States, 66208
United States, Kentucky
Kentucky Pediatric Research
Bardstown, Kentucky, United States, 40004
L-MARC Research Center
Louisville, Kentucky, United States, 40213
United States, Louisiana
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States, 70119
United States, Massachusetts
Community Clinical Research Network
Marlborough, Massachusetts, United States, 01752
United States, Michigan
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, United States, 48104
Beyer Research
Kalamazoo, Michigan, United States, 49009
United States, Minnesota
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
United States, Mississippi
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States, 38654
United States, Missouri
ClinVest
Springfield, Missouri, United States, 65810
United States, Nebraska
Meridian Clinical Research Norfolk
Norfolk, Nebraska, United States, 68701
Quality Clinical Research
Omaha, Nebraska, United States, 68114
Meridian Clinical Research, LLC
Omaha, Nebraska, United States, 68134
Clinical Research Advantage, Inc.
Omaha, Nebraska, United States, 68144
United States, Nevada
Altea Research
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Advocare Berlin Medical Associates
Berlin, New Jersey, United States, 08009
Amici Clinical Research
Martinsville, New Jersey, United States, 08836
Princeton Center for Clinical Research
Skillman, New Jersey, United States, 08558
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
United States, New Mexico
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States, 87102
United States, New York
Dent Neurologic Institute
Amherst, New York, United States, 14226
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
Central New York Clinical Research
Manlius, New York, United States, 13104
Clinilabs
New York, New York, United States, 10019
Rochester Clinical Research
Rochester, New York, United States, 14609
Upstate Clinical Research Associates
Williamsville, New York, United States, 14221
United States, North Dakota
Plains Medical Clinic
Fargo, North Dakota, United States, 58104
United States, Ohio
Radiant Akron
Akron, Ohio, United States, 44311
Radiant Research Cincinnati
Cincinnati, Ohio, United States, 45236
Rapid Medical Research
Cleveland, Ohio, United States, 44122
Ohio Clinical Research, LLC
Lyndhurst, Ohio, United States, 44124
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Summit Research Network
Portland, Oregon, United States, 97210
Oregon Center for Clinical Investigations
Salem, Oregon, United States, 97301
United States, Pennsylvania
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
Suburban Research Associates
Media, Pennsylvania, United States, 19063
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, United States, 19114
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States, 15683
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States, 15478
United States, South Carolina
Radiant Research
Anderson, South Carolina, United States, 29621
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
United States, South Dakota
Meridian Clinical Research
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
Volunteer Research Group
Knoxville, Tennessee, United States, 37920
CNS Healthcare - Memphis
Memphis, Tennessee, United States, 38119
Trinity Clinical Research
Tullahoma, Tennessee, United States, 37388
United States, Texas
FutureSearch Trials of Neurology
Austin, Texas, United States, 78731
Tekton Research
Austin, Texas, United States, 78745
DiscoveResearch
Bryan, Texas, United States, 77802
FutureSearch Trials
Dallas, Texas, United States, 75231
Earle Research
Houston, Texas, United States, 77058
Research Trials WorldWide
Humble, Texas, United States, 77338
Radiant Research San Antonio
San Antonio, Texas, United States, 78217
ClinPoint Trials
Waxahachie, Texas, United States, 75165
United States, Utah
Foothill Family Draper Clinic
Draper, Utah, United States, 84020
Advanced Research Institute
Ogden, Utah, United States, 84405
Advanced Clinical Research
West Jordan, Utah, United States, 84088
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States, 23454
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
North Seattle Women's Group
Seattle, Washington, United States, 98105
United States, Wisconsin
SSM Dean Health Research
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Joel Trugman, MD Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03700320     History of Changes
Other Study ID Numbers: 3101-302-002
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases