Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment 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: NCT03777059
Recruitment Status : Completed
First Posted : December 17, 2018
Results First Posted : July 9, 2021
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE December 13, 2018
First Posted Date  ICMJE December 17, 2018
Results First Submitted Date  ICMJE June 18, 2021
Results First Posted Date  ICMJE July 9, 2021
Last Update Posted Date July 9, 2021
Actual Study Start Date  ICMJE December 14, 2018
Actual Primary Completion Date June 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2021)
Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period [ Time Frame: Baseline (Day -28 to Day -1) to Week 12 ]
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects model for repeated measures (MMRM) was used for analysis.
Original 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2021)
  • Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period [ Time Frame: Baseline (Day-28 to Day -1) to Week 12 ]
    Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. MMRM was used for analysis.
  • Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period [ Time Frame: Baseline (Day-28 to Day -1) to Week 12 ]
    Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of acute medication use days during the last 28 days of the Baseline phase, from Day -28 to -1. A negative change from Baseline indicates improvement. MMRM was used for the analysis.
  • Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days [ Time Frame: Baseline (Day -28 to Day -1) to Week 12 ]
    Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged.
  • Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
    MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: role function-restrictive (questions 1-7, score range 7 to 42) assesses how migraines limit one's daily social and work-related activities; role function-preventive (questions 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the emotional function (questions 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale where 1=none of the time and 6=all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores from Baseline indicate better quality of life. MMRM was used for the analysis.
  • Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine-Diary (AIM-D) Across the 12-Week Treatment Period [ Time Frame: Baseline (Day -28 to Day -1) to Week 12 ]
    The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) performance of daily activities domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.
  • Change From Baseline in Mean Monthly Physical Impairment Domain Score of the Activity Impairment in Migraine- Diary (AIM-D) Across the 12-Week Treatment Period [ Time Frame: Baseline (Day -28 to Day -1) to Week 12 ]
    The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) physical impairment domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.
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 12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment 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
    Atogepant tablet
  • Drug: Placebo
    Placebo-matching atogepant tablets
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo-matching atogepant tablets orally once daily for 12 weeks.
    Intervention: Drug: Placebo
  • Experimental: Atogepant 10 mg
    Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
    Interventions:
    • Drug: Atogepant
    • Drug: Placebo
  • Experimental: Atogepant 30 mg
    Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
    Interventions:
    • Drug: Atogepant
    • Drug: Placebo
  • Experimental: Atogepant 60 mg
    Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
    Interventions:
    • Drug: Atogepant
    • Drug: Placebo
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2020)
910
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2018)
872
Actual Study Completion Date  ICMJE June 19, 2020
Actual Primary Completion Date June 19, 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 (e.g., 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 information is only displayed when the study is recruiting subjects
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
Study Director: Joel Trugman, MD Allergan
PRS Account Allergan
Verification Date June 2021

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