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

Allergan

Status and phase: Completed; Phase 3

Conditions: Episodic Migraine

Treatments: Drug: Placebo; Drug: Atogepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03777059

3101-301-002

Details and patient eligibility

About

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.

Enrollment: 910 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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910 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo-matching atogepant tablets orally once daily for 12 weeks.

Treatment:

Drug: Placebo

Atogepant 10 mg

Experimental group

Description:

Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.

Treatment:

Drug: Placebo

Drug: Atogepant

Atogepant 30 mg

Experimental group

Description:

Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.

Treatment:

Drug: Placebo

Drug: Atogepant

Atogepant 60 mg

Experimental group

Description:

Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.

Treatment:

Drug: Placebo

Drug: Atogepant