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

Phase 1

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

Registration Number: EUCTR2020-002470-27-DK

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 670

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 639
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of treatment with atogepant 60 mg once daily when administered over 156 weeks for the prevention of migraine in participants with CM or EM.;Secondary Objective: N/A;Primary end point(s): Percentage of Participants with at least 1 Treatment Emergent Adverse Event;Timepoint(s) of evaluation of this end point: 156 weeks

Secondary Outcome Measures

Name	Time	Method

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