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A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507096-21-00
Acronym
3101-312-002
Enrollment
382
Registered
2023-12-18
Start date
2021-08-16
Completion date
2025-10-09
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic or Episodic Migraine (Migraine without aura, migraine with aura, or chronic migraine)

Brief summary

Percentage of Participants with at Least 1 Treatment Emergent Adverse Event

Detailed description

Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator, Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator, Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator, Percentage of Participants with Clinically Significant Laboratory values, ECG findings or Vital Sign measures as assessed by Investigator; and results of the CSSRS Scale.

Interventions

DRUGAtogepant

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event—

Secondary

MeasureTime frame
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator, Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator, Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator, Percentage of Participants with Clinically Significant Laboratory values, ECG findings or Vital Sign measures as assessed by Investigator; and results of the CSSRS Scale.—

Countries

Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026