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Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

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ClinicalTrials.gov Identifier: NCT03855137
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE February 26, 2019
Last Update Posted Date July 14, 2021
Actual Study Start Date  ICMJE March 11, 2019
Estimated Primary Completion Date February 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
Change from baseline in mean monthly migraine days across the treatment period [ Time Frame: 12 Weeks ]
Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
Change from baseline in mean monthly migraine days across the treatment period [ Time Frame: 12 Weeks ]
Efficacy assessments will be based on information recorded by the participant. An eDiary will be used daily at home to collect data on headache duration, headache characteristics, symptoms, and acute medication use, which will be collectively applied to define migraine days and headache days
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
  • 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 prior to the randomization date.
  • 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 migraine days during the last 28 days prior to the randomization date.
  • At least a 50% reduction in 3-month average of monthly migraine days [ Time Frame: 12 Weeks ]
    Defined as participants with at least a 50% reduction from baseline in monthly migraine days
  • Change from baseline in MSQ v2.1 Role Function-Restrictive domain score at Week 12 [ Time Frame: 12 Weeks ]
    The 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 3 domains: Role Function Restrictive assesses how migraines limit one's daily social and work-related activities; Role Function Preventive assesses how migraines prevent these activities; and the Emotional Function domain assesses the emotions associated with migraines.
  • Change from baseline in mean monthly Performance of Daily Activities domain score of the AIM-D across the 12-week treatment period. (Excluding participants from Europe & Canada) [ Time Frame: 12 Weeks ]
    The Activity Impairment in Migraine-Diary (AIM-D) is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items).
  • Change from baseline in mean monthly Physical Impairment domain score of the AIM-D across the 12-week treatment period. (Excluding participants from Europe & Canada) [ Time Frame: 12 Weeks ]
    The Activity Impairment in Migraine-Diary (AIM-D) is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items).
  • Change from baseline in the Headache Impact Test (HIT-6) total score at Week 12 (Participants in Europe and Canada only) [ Time Frame: 12 Weeks ]
    The HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • Change from baseline in mean monthly headache days across the 12-week treatment period [ Time Frame: 12 Weeks ]
    Efficacy assessments will be based on information recorded by the participant. An eDiary will be used daily at home to collect data on headache duration, headache characteristics, symptoms, and acute medication use, which will be collectively applied to define migraine days and headache days
  • Change from baseline in mean monthly acute medication use days across the 12-week treatment period [ Time Frame: 12 Weeks ]
    Efficacy assessments will be based on information recorded by the participant. An eDiary will be used daily at home to collect data on headache duration, headache characteristics, symptoms, and acute medication use, which will be collectively applied to define migraine days and headache days
  • Proportion of participants with at least a 50% reduction in mean monthly migraine days across the 12-week treatment period [ Time Frame: 12 Weeks ]
    Efficacy assessments will be based on information recorded by the participant. An eDiary will be used daily at home to collect data on headache duration, headache characteristics, symptoms, and acute medication use, which will be collectively applied to define migraine days and headache days
  • Change from baseline in MSQ v2.1 Role Function-Restrictive domain score at Week 12 [ Time Frame: 12 Weeks ]
    The 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 3 domains: Role Function Restrictive assesses how migraines limit one's daily social and work-related activities; Role Function Preventive assesses how migraines prevent these activities; and the Emotional Function domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from "none of the time" to "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 indicate better quality of life.
  • 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 ]
    The Activity Impairment in Migraine - Diary (AIM-D) is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment. Participants are asked to rate the level of difficulty experienced in the past 24 hours with 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 ]
    The Activity Impairment in Migraine - Diary (AIM-D) is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment. Participants are asked to rate the level of difficulty experienced in the past 24 hours with 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."
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)
Brief Summary This study will evaluate the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study includes a 12-week treatment period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Migraine
Intervention  ICMJE
  • Drug: Atogepant 30 mg
    Tablets containing 30 mg atogepant
  • Drug: Atogepant 60 mg
    Tablets containing 60 mg atogepant
  • Drug: Placebo
    30 mg/60 mg tablets containing atogepant-matching placebo
Study Arms  ICMJE
  • Active Comparator: Atogepant 30 mg BID
    Taken twice daily
    Intervention: Drug: Atogepant 30 mg
  • Active Comparator: Atogepant 60 mg
    Taken once daily
    Intervention: Drug: Atogepant 60 mg
  • Placebo Comparator: Placebo
    Taken twice daily
    Intervention: Drug: Placebo
Publications * Min KC, Kraft WK, Bondiskey P, Colón-González F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.

*   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: February 25, 2019)
750
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 11, 2022
Estimated Primary Completion Date February 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least a 1-year history of CM consistent with a diagnosis according to the ICHD-3, 2018
  • Age of the participant at the time of migraine onset < 50 years
  • Confirmation of headache/migraine headache day frequency as follows:
  • History of, on average, ≥ 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND
  • ≥ 15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND
  • ≥ 8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary
  • Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,

Exclusion Criteria:

  • Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine
  • Has a current diagnosis of 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
  • Woman 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 at Visit 1 and Visit 2.
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 Registry Team 877-277-8566 IR-CTRegistration@allergan.com
Listed Location Countries  ICMJE United States,   Australia,   Canada,   China,   Czechia,   Denmark,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03855137
Other Study ID Numbers  ICMJE 3101-303-002
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
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Allergan
Verification Date July 2021

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