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

  • End date
    Jun 21, 2023
  • participants needed
  • sponsor
Updated on 22 July 2021
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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

Condition Episodic Migraine, Chronic Migraine
Treatment Atogepant 60 mg
Clinical Study IdentifierNCT04686136
Last Modified on22 July 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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