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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.