Phase 3 Open label clinical trial with oral Atogepant for the prevention of migraine

Phase 1

Conditions: MedDRA version: 22.0Level: LLTClassification code: 10082019Term: Episodic migraine Class: 10029205
MedDRA version: 20.0Level: HLTClassification code: 10027603Term: Migraine headaches Class: 10029205
MedDRA version: 20.0Level: PTClassification code: 10052787Term: Migraine without aura Class: 100000004852
MedDRA version: 20.0Level: PTClassification code: 10027607Term: Migraine with aura Class: 100000004852
MedDRA version: 21.1Level: LLTClassification code: 10066636Term: Chronic migraine Class: 10029205
MedDRA version: 20.0Level: PTClassification code: 10027599Term: Migraine Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Chronic or Episodic Migraine (Migraine without aura, migraine with aura, or chronic migraine)

Registration Number: CTIS2023-507096-21-00

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 596

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.