Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Eptinezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05064371

19140B

Details and patient eligibility

About

This study is an open label extension study, which means that the participants from the Lead-in Study 19140A (NCT04921384) can join this study, if they meet the study Eligibility Criteria, and continue to receive the study drug eptinezumab. The main goal of this study is to investigate long-term safety and tolerability of eptinezumab in Japanese migraine participants.

Full description

The total study duration from the Baseline Visit to the Safety Follow-up Visit is approximately 68 weeks and includes an Open-Label Treatment Period (60 weeks) and a Safety Follow-up Period (8 weeks).

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• The participant has completed the Primary Outcome Visit (Visit 5) of the lead-in Study 19140A immediately prior to enrolment into this study.
• The participant is indicated for 60-week preventive treatment of chronic migraine with eptinezumab according to the clinical opinion of the investigator.

Key Exclusion Criteria:

• The participant has a serious adverse event (SAE) or a moderate or severe ongoing AE from the Lead-In study considered a potential safety risk by the investigator.
• The participant has a clinically relevant change in vital signs or electrocardiogram (ECG) from the Lead-In study considered a potential safety risk by the investigator.
• The participant has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Eptinezumab

Experimental group

Description:

Participants will receive eptinezumab 100 milligrams (mg) at the Baseline visit (Week 0) and eptinezumab 100 mg or 300 mg (depending upon the treatment response) at Weeks 12, 24, 36, and 48 by intravenous (IV) infusions.

Treatment:

Drug: Eptinezumab