Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine

NCT ID: NCT03303105

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-07
• Study Completion Date: 2020-06-16

Brief Summary

To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of TEV-48125 (at 225 mg once monthly [except for a loading dose of 675 mg for CM patients] or at 675 mg every 3 months) for the preventive treatment of Chronic Migraine and Episodic Migraine patients

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TEV-48125 (225 mg/1 month) group

TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly \[except for a loading dose of 675 mg in subjects with CM\]).

Group Type: EXPERIMENTAL

TEV-48125

Intervention Type: DRUG

TEV-48125 will be administered subcutaneously once every 4 weeks.

TEV-48125 (675 mg/3 month) group

TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).

Group Type: EXPERIMENTAL

TEV-48125

Intervention Type: DRUG

TEV-48125 will be administered subcutaneously once every 12 weeks.

Interventions

TEV-48125

TEV-48125 will be administered subcutaneously once every 4 weeks.

Intervention Type: DRUG

TEV-48125

TEV-48125 will be administered subcutaneously once every 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition [beta version] criteria) or clinical judgment suggests a migraine diagnosis
• Patient fulfills the criteria for Chronic migraine or Episodic migraine in baseline information collected during the 28 day screening period
• Not using preventive migraine medications for migraine or other medical conditions or using no more than 2 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.
• Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator.

Exclusion Criteria

• Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takehisa Matsumaru

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Saitama Medical University Hospital

Iruma, , Japan

Countries

Japan

References

Sakai F, Suzuki N, Ning X, Ishida M, Usuki C, Iba K, Isogai Y, Koga N. Long-Term Safety and Tolerability of Fremanezumab for Migraine Preventive Treatment in Japanese Outpatients: A Multicenter, Randomized, Open-Label Study. Drug Saf. 2021 Dec;44(12):1355-1364. doi: 10.1007/s40264-021-01119-2. Epub 2021 Oct 23.

Reference Type: DERIVED

PMID: 34687446 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

JapicCTI-173726

Identifier Type: OTHER

Identifier Source: secondary_id

406-102-00003

Identifier Type: -

Identifier Source: org_study_id