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

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: 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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Migraine, With or Without Aura Drug: Atogepant Drug: Placebo-matching Atogepant Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 834 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : September 6, 2016
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : April 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine
Drug Information available for: Atogepant

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks.
 Drug: Placebo-matching Atogepant
Placebo-matching atogepant capsule.
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.
 Drug: Atogepant
Atogepant capsule.
Other Name: AGN-241689

Drug: Placebo-matching Atogepant
Placebo-matching atogepant capsule.
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.
 Drug: Atogepant
Atogepant capsule.
Other Name: AGN-241689

Drug: Placebo-matching Atogepant
Placebo-matching atogepant capsule.
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.
 Drug: Atogepant
Atogepant capsule.
Other Name: AGN-241689
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.
 Drug: Atogepant
Atogepant capsule.
Other Name: AGN-241689

Drug: Placebo-matching Atogepant
Placebo-matching atogepant capsule.
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.
 Drug: Atogepant
Atogepant capsule.
Other Name: AGN-241689


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848326


Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Joel Trugman, MD Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] September 11, 2017
Statistical Analysis Plan  [PDF] May 22, 2018

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02848326    
Other Study ID Numbers: CGP-MD-01
First Posted: July 28, 2016    Key Record Dates
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases