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

Phase 2

Completed

• Conditions: Migraine, With or Without Aura
• Interventions: Drug: Atogepant; Drug: Placebo-matching Atogepant

• Registration Number: NCT02848326
• Lead Sponsor: Allergan

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 available

Study Timeline

• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-28
• Study Start: 2016-09-06
• Primary Completion: 2018-04-02
• Study Completion: 2018-04-23
• Status Verified: 2018-11
• Results First Submitted: 2018-11-13
• Results First Submitted QC: 2018-11-13
• Last Update Submitted: 2018-11-13
• Results First Posted: 2018-12-06
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 834

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atogepant 60 mg BID	Atogepant	Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Atogepant 30 mg BID	Atogepant	Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Placebo	Placebo-matching Atogepant	Placebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks.
Atogepant 60 mg QD	Placebo-matching Atogepant	Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
Atogepant 30 mg QD	Placebo-matching Atogepant	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.
Atogepant 10 mg QD	Placebo-matching Atogepant	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.
Atogepant 60 mg QD	Atogepant	Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
Atogepant 10 mg QD	Atogepant	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.
Atogepant 30 mg QD	Atogepant	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period	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

Name	Time	Method
Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period	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	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	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.

Trial Locations

Locations (73)

Achieve Clinical Research; 🇺🇸 Birmingham, Alabama, United States

Radiant Research, Inc.; 🇺🇸 Jamaica, New York, United States

The Research Center of Southern California, LLC; 🇺🇸 Carlsbad, California, United States

Neuro-Pain Medical Center, Inc; 🇺🇸 Fresno, California, United States

Irvine Center for Clinical Research; 🇺🇸 Irvine, California, United States

Downtown LA Research Center, Inc.; 🇺🇸 Los Angeles, California, United States

Excell Research; 🇺🇸 Oceanside, California, United States

Artemis Institute for Clinical Research; 🇺🇸 San Marcos, California, United States

Diablo Clinical Research Inc; 🇺🇸 Walnut Creek, California, United States

Advanced Neurosciences Research; 🇺🇸 Fort Collins, Colorado, United States

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