NCT04686136
Brief summary
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
Interventional study
- 1
- 2
- 3
- 4
Age:
From 18 Years to 80 Years.
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.
