A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine

AbbVie

Status and phase

Active, not recruiting

Phase 3

Conditions

Chronic Migraine

Episodic Migraine

Treatments

Drug: Atogepant 60 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT04686136

2020-002470-27 (EudraCT Number)

3101-312-002

Details and patient eligibility

About

This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine

Enrollment

596 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.

Exclusion criteria

Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative.
Participants with an ECG indicating clinically significant abnormalities at Visit 1.
Participants with hypertension at Visit 1.
Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.