A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients

NCT04355117 | Completed Phase 3 Results

• 1 other identifier: 406-102-00005
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This trial assesses the safety of TEV-48125 when subcutaneously self-administered in Japanese migraine patients using an autoinjector (AI) at home. Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses. The first dose will be self-administered at the trial site under the supervision of the investigator and the second dose will be self-administered at home.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)

  * TEAEs were defined as AEs that started after the start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was worsening after the start of IMP treatment. * The number of subjects with TEAEs were provided by self-administration at the trial site and by self-administration at home. 1. For TEAEs following self-administration at the trial site, TEAEs that occurred after self-administration at the trial site (Baseline) but before self-administration at home (Visit 3) were tabulated. 2. For TEAEs following self-administration at home, TEAEs that occurred after self-administration at home but before the end of the trial were tabulated.

  [1] Baseline (Day 1) to Day 28, [2] Visit 3 (Day 29) up to end of treatment (Day 57)

Secondary Outcomes (4)

• Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI

  Baseline (Day 1) and Visit 3 (Day 29)

• Execution Status of Self-administration - Leakage of Drug Solution on the Skin

  Baseline (Day 1) and Visit 3 (Day 29)

• Subject Compliance With the Self-administration Procedure

  Baseline (Day 1) and Visit 3 (Day 29)

• Number of Deficiencies With the AI Device

  Baseline (Day 1) and Visit 3 (Day 29)

Study Arms (1)

Treatment: TEV-48125

EXPERIMENTAL

Drug: Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.

Interventions

Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses. DRUG

Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.

Treatment: TEV-48125

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 ICHD-3 criteria) diagnosis for ≥12 months prior to giving informed consent.
• Patient fulfills any of the migraine criteria(according to the ICHD-3 criteria) on ≥4 days in baseline information collected during the 28-day screening period

You may not qualify if:

• History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
• Prior exposure to a monoclonal antibody targeting (CGRP) pathway meeting the following conditions:
• Less than 5 months has passed since the final administration of AMG334, ALD304, or LY2951742.
• Less than 1 year has passed since the final administration of TEV-48125

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sendai Zutsu No-Shinkei Clinic

Sendai, Japan

Location

MeSH Terms

Conditions

Migraine Disorders

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: April 21, 2020
• Study Start: June 17, 2020
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: October 28, 2021
• Results First Posted: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Locations

JP (1)