Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date March 25, 2019
Actual Study Start Date  ICMJE October 8, 2018
Estimated Primary Completion Date June 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event [ Time Frame: Across the 52-week treatment period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03700320 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
  • Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator [ Time Frame: Across the 52-week treatment period ]
  • Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator [ Time Frame: Across the 52-week treatment period ]
  • Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator [ Time Frame: Across the 52-week treatment period ]
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
Official Title  ICMJE 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.
Brief Summary Safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Episodic Migraine
Intervention  ICMJE
  • Drug: Atogepant 60 mg
    Tablets containing atogepant 60 mg
  • Drug: Standard of Care (SOC) Migraine Prevention Medication
    Medication recognized as safe and effective for the prevention of migraine
Study Arms  ICMJE
  • Active Comparator: Atogepant 60 mg
    Taken once daily
    Intervention: Drug: Atogepant 60 mg
  • Active Comparator: Oral SOC migraine prevention medication
    Taken once daily
    Intervention: Drug: Standard of Care (SOC) Migraine Prevention Medication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2018)
700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 9, 2020
Estimated Primary Completion Date June 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03700320
Other Study ID Numbers  ICMJE 3101-302-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joel Trugman, MD Allergan
PRS Account Allergan
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP