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

NCT03303105 | Completed Phase 3 Results

• 2 other identifiers: 406-102-00003JapicCTI-173726
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE)

  * TEAEs are defined as the AEs that started after trial investigational medicinal product (IMP) treatment. Multiple occurrences of TEAEs are counted once per MedDRA preferred term. * Specific AE terms are provided in the Adverse Event section.

  Baseline (Day 0) up to follow-up visit (Day 562)

Secondary Outcomes (2)

• Mean Change From Baseline in the Monthly (28 Day) Average Number of Migraine Days

  Baseline, Month 12

• Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity

  Baseline, Month 12

Study Arms (2)

TEV-48125 (225 mg/1 month) group

EXPERIMENTAL

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

Drug: TEV-48125

TEV-48125 (675 mg/3 month) group

EXPERIMENTAL

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

Drug: TEV-48125

Interventions

TEV-48125 DRUG

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

TEV-48125 (225 mg/1 month) group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Saitama Medical University Hospital

Iruma, Japan

Location

Related Publications (1)

• 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.

  PMID: 34687446 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

fremanezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Takehisa Matsumaru

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 5, 2017
• Study Start: December 7, 2017
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: February 17, 2023
• Results First Posted: July 16, 2021

Record last verified: 2023-02

Locations

JP (1)