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Trial record 32 of 1121 for:    migraine

To Evaluate the Safety and Tolerability of Atogepant 10mg, 30 mg and 60 mg Once a Day for the Prevention of Migraine in Participants With Episodic Migraine

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ClinicalTrials.gov Identifier: NCT03777059
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE December 13, 2018
First Posted Date  ICMJE December 17, 2018
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE December 14, 2018
Estimated Primary Completion Date February 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
Change from baseline in mean monthly migraine days across the 12-week treatment period [ Time Frame: 12 weeks ]
Baseline is defined as the number of migraine days during the last 28 days of the baseline phase, ie, Day -28 to -1.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03777059 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
  • Change from baseline in mean monthly headache days across the 12-week treatment period. [ Time Frame: 12 Weeks ]
    Baseline is defined as the number of migraine days during the last 28 days of the baseline phase, ie, Day -28 to -1.
  • Change from baseline in mean monthly acute medication use days across the 12-week treatment period. [ Time Frame: 12 weeks ]
    Baseline is defined as the number of acute medication use days during the last 28 days of the baseline phase, ie, Day-28 to -1.
  • Proportion of participants with at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. [ Time Frame: 12 weeks ]
    Defined as participants with at least a 50% reduction from baseline in monthly migraine days,
  • Change from baseline in mean monthly performance of daily activities domain score of the AIM-D across the 12-week treatment period. [ Time Frame: 12 weeks ]
    Baseline is defined as the monthly performance of daily activities domain score during the last 28 days of the baseline phase, ie, Day -28 to -1. The Activity Impairment in Migraine - Diary (AIM-D) is a 9-item Patient Reported Outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale ranging from "Not difficult at all," "A little difficult," "Somewhat difficult," "Very difficult," "Extremely difficult," and "I could not do it at all."
  • Change from baseline in mean monthly physical impairment domain score of the AIM-D across the 12-week treatment period. [ Time Frame: 12 weeks ]
    Baseline is defined as the monthly physical impairment domain score during the last 28 days of the baseline phase, ie, Day -28 to -1. The Activity Impairment in Migraine - Diary (AIM-D) is a 9-item Patient Reported Outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale ranging from "Not difficult at all," "A little difficult," "Somewhat difficult," "Very difficult," "Extremely difficult," and "I could not do it at all."
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
  • Change from baseline in mean monthly headache days across the 12-week treatment period. [ Time Frame: 12 Weeks ]
    Baseline is defined as the number of migraine days during the last 28 days of the baseline phase, ie, Day -28 to -1.
  • Change from baseline in mean monthly acute medication use days across the 12-week treatment period. [ Time Frame: 12 weeks ]
    Baseline is defined as the number of acute medication use days during the last 28 days of the baseline phase, ie, Day-28 to -1.
  • Proportion of participants with at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. [ Time Frame: 12 weeks ]
    Defined as participants with at least a 50% reduction from baseline in monthly migraine days,
  • Change from baseline in mean monthly performance of daily activities domain score of the AIM-D across the 12-week treatment period. [ Time Frame: 12 weeks ]
    Baseline is defined as the monthly performance of daily activities domain score during the last 28 days of the baseline phase, ie, Day -28 to -1. The Activity Impairment in Migraine - Diary (AIM-D) is a 9-item Patient Reported Outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale ranging from "Not difficult at all," "A little difficult," "Somewhat difficult," "Verydifficult," "Extremely difficult," and "I could not do it at all."
  • Change from baseline in mean monthly physical impairment domain score of the AIM-D across the 12-week treatment period. [ Time Frame: 12 weeks ]
    Baseline is defined as the monthly physical impairment domain score during the last 28 days of the baseline phase, ie, Day -28 to -1. The Activity Impairment in Migraine - Diary (AIM-D) is a 9-item Patient Reported Outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale ranging from "Not difficult at all," "A little difficult," "Somewhat difficult," "Verydifficult," "Extremely difficult," and "I could not do it at all."
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 Atogepant 10mg, 30 mg and 60 mg Once a Day for the Prevention of Migraine in Participants With Episodic Migraine
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine (Advance)
Brief Summary To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Episodic Migraine
Intervention  ICMJE
  • Drug: Atogepant 30 mg
    Tablets containing atogepant 30 mg
  • Drug: Atogepant 60 mg
    Tablets containing atogepant 60 mg
  • Drug: Placebo
    10 mg, 30 mg and 60 mg tablets containing atogepant-matching placebo
  • Drug: Atogepant 10 mg
    Tablets containing atogepant 10 mg
Study Arms  ICMJE
  • Active Comparator: Atogepant 30 mg
    Taken once daily
    Intervention: Drug: Atogepant 30 mg
  • Active Comparator: Atogepant 60 mg
    Taken once daily
    Intervention: Drug: Atogepant 60 mg
  • Placebo Comparator: Placebo
    Taken once daily
    Intervention: Drug: Placebo
  • Active Comparator: Atogepant 10 mg
    Taken once daily
    Intervention: Drug: Atogepant 10 mg
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2018)
872
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 5, 2020
Estimated Primary Completion Date February 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
  • Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
  • History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine
  • Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
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: Clinical Trials Registy Team 877-277-8566 IR-CTRegistration@allergan.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03777059
Other Study ID Numbers  ICMJE 3101-301-002
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 Not Provided
PRS Account Allergan
Verification Date September 2019

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