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Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

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ClinicalTrials.gov Identifier: NCT02848326
Recruitment Status : Completed
First Posted : July 28, 2016
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE July 26, 2016
First Posted Date  ICMJE July 28, 2016
Results First Submitted Date  ICMJE November 13, 2018
Results First Posted Date  ICMJE December 6, 2018
Last Update Posted Date December 6, 2018
Actual Study Start Date  ICMJE September 6, 2016
Actual Primary Completion Date April 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period [ Time Frame: Baseline (First 28 Days of Screening/Baseline Period) 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 and acute symptomatic medication use. The 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. Negative change from Baseline indicates improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2016)
Change from Baseline in the Mean Number of Migraine/Probable Migraine Headache Days [ Time Frame: Baseline, Last 28 days of the treatment period ending with Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period [ Time Frame: Baseline (First 28 Days of Screening/Baseline Period) 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 and acute symptomatic medication use. The 4-week (monthly) headache days was 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. Negative change from Baseline indicates improvement.
  • Percentage of Participants With at Least a 50% Reduction in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period [ Time Frame: Baseline (First 28 Days of Screening/Baseline Period) 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 and acute symptomatic medication use. The 4-week migraine days=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 Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period [ Time Frame: Baseline (First 28 Days of Screening/Baseline Period) to Week 12 ]
    Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The 4-week (monthly) 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. A negative change from Baseline indicates improvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2016)
  • Change from Baseline in the Number of Headache Days [ Time Frame: Baseline, Last 28 days of the treatment period ending with Week 12 ]
  • Percentage of Participants with at Least a 50% Reduction in Migraine/Probable Migraine Headache Days [ Time Frame: Baseline, Last 28 days of the treatment period ending with Week 12 ]
  • Change from Baseline in the Activities of Daily Living (ADL) Domain Score of the ACM-I (Assessment of Chronic Migraine Impact) using a 24 Item Questionnaire [ Time Frame: Baseline, Week 12 ]
  • Percentage of Participants "Satisfied" or "Extremely Satisfied" with Migraine Prevention [ Time Frame: Week 12 ]
  • Change from Baseline in the Number of Triptan Use Days [ Time Frame: Baseline, Last 28 days of the treatment period ending with Week 12 ]
  • Change from Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 using a 6-Question Assessment [ Time Frame: Baseline, Week 12 ]
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 Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention
Official Title  ICMJE A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Dosing Regimens Of Oral AGN-241689 In Episodic Migraine Prevention
Brief Summary This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Migraine, With or Without Aura
Intervention  ICMJE
  • Drug: Atogepant
    Atogepant capsule.
    Other Name: AGN-241689
  • Drug: Placebo-matching Atogepant
    Placebo-matching atogepant capsule.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks.
    Intervention: Drug: Placebo-matching Atogepant
  • Experimental: Atogepant 10 mg QD
    Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
    Interventions:
    • Drug: Atogepant
    • Drug: Placebo-matching Atogepant
  • Experimental: Atogepant 30 mg QD
    Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
    Interventions:
    • Drug: Atogepant
    • Drug: Placebo-matching Atogepant
  • Experimental: Atogepant 30 mg BID
    Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
    Intervention: Drug: Atogepant
  • Experimental: Atogepant 60 mg QD
    Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
    Interventions:
    • Drug: Atogepant
    • Drug: Placebo-matching Atogepant
  • Experimental: Atogepant 60 mg BID
    Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
    Intervention: Drug: Atogepant
Publications * Goadsby PJ, Dodick DW, Ailani J, Trugman JM, Finnegan M, Lu K, Szegedi A. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Lancet Neurol. 2020 Sep;19(9):727-737. doi: 10.1016/S1474-4422(20)30234-9. Erratum in: Lancet Neurol. 2020 Nov;19(11):e10.

*   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: March 5, 2018)
834
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2016)
810
Actual Study Completion Date  ICMJE April 23, 2018
Actual Primary Completion Date April 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has at least a 1-year history of migraine with or without aura
  • Age of the patient at the time of migraine onset < 50 years
  • History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment
  • Demonstrated compliance with e-diary

Exclusion Criteria:

  • Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine
  • Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
  • Difficulty distinguishing migraine headache from other headaches
  • Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption
  • Has a history of hepatitis within previous 6 months
  • Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
  • Pregnant or nursing females
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 NCT02848326
Other Study ID Numbers  ICMJE CGP-MD-01
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 November 2018

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