12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine

Purpose

To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine.

Condition

  • Episodic Migraine

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • At least a 1-year history of migraine with or without aura consistent with a diagnosis. - Age of the participant at the time of migraine onset <50 years.

Exclusion Criteria

  • Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine. - Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (e.g., 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. - Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Placebo-matching atogepant tablets orally once daily for 12 weeks.
  • Drug: Placebo
    Placebo-matching atogepant tablets
Experimental
Atogepant 10 mg 		Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
  • Drug: Atogepant
    Atogepant tablet
  • Drug: Placebo
    Placebo-matching atogepant tablets
Experimental
Atogepant 30 mg 		Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
  • Drug: Atogepant
    Atogepant tablet
  • Drug: Placebo
    Placebo-matching atogepant tablets
Experimental
Atogepant 60 mg 		Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
  • Drug: Atogepant
    Atogepant tablet
  • Drug: Placebo
    Placebo-matching atogepant tablets

More Details

Status
Completed
Sponsor
Allergan

Study Contact