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

Conditions

• Migraine, With or Without Aura

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Atogepant — DRUG
  Atogepant capsule.
• Placebo-matching Atogepant — DRUG
  Placebo-matching atogepant capsule.

Study Details

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.

Key Dates

Start date

Sep 6, 2016

Status verified

Nov 2018

Primary completion

Apr 2, 2018

Completion

Apr 23, 2018

Study Design

Enrollment

834 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Placebo Comparator: Placebo
  Placebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks.
• 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.
• 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.
• 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.
• 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.
• 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.

Primary Outcome Measure

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 ]

Locations (75)

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