Skip to main content
OpenTrials
Completed

NCT Number: NCT04355117

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sendai Zutsu No-Shinkei Clinic

Sendai, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

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

    • 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.
    • 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.
    • For TEAEs following self-administration at home, TEAEs that occurred after self-administration at home but before the end of the trial were tabulated.

Secondary outcomes

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

    Time frame: Baseline (Day 1) and Visit 3 (Day 29)

    Following self-administration at the trial site and at home, the AI was checked to see whether or not all of the drug solution had been injected and the appropriate description of the amount of drug solution remaining in the AI was recorded based on th following 5-point scale (0 to 4) measure.

    • 0: All drug solution has been injected
    • 1: Approximately 1/4 of the drug solution remaining
    • 2: Approximately 1/2 of the drug solution remaining
    • 3: Approximately 3/4 of the drug solution remaining
    • 4: Almost all of the drug solution remaining

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

    Time frame: Baseline (Day 1) and Visit 3 (Day 29)

    Following self-administration at the trial site and at home, the injection site was observed for any leakage of drug solution on the skin was recorded based on the following 5-point scale (0 to 4) measure. Criteria 0, 1, and 2 on the 5-point scale measure were deemed to represent a successful self-injection.

    • 0: No sign of drug solution on the skin
    • 1: Slight wetness on the skin (mist)
    • 2: Approx. 1/5 (0.3 mL) of the drug solution observed on the skin (most of the drug solution subcutaneously administered)
    • 3: Approx. 1/2 (0.75 mL) of the drug solution observed on the skin (ie, approx. 1/2 of drug solution subcutaneously administered)
    • 4: Almost all of the drug solution observed on the skin (ie, little or no drug solution subcutaneously administered)

  3. Subject Compliance With the Self-administration Procedure

    Time frame: Baseline (Day 1) and Visit 3 (Day 29)

    Subject compliance with the self-administration procedure was evaluated based on information recorded on a checklist.

    Compliance with each of the procedures during IMP preparation, injection administration, and after injection was verified by checking the "Yes" or "No" responses marked for each item on the checklist. Based on this checklist, the investigator judged adherence to self-administration procedure.

  4. Number of Deficiencies With the AI Device

    Time frame: Baseline (Day 1) and Visit 3 (Day 29)

    A deficiency with the AI device (AI device deficiency) is defined as any defect in the quality, safety, or performance of the device, such as mechanical breakage and malfunction, no matter whether it is caused by design, manufacture, dispensing, storage,or use.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-label Trial to Evaluate the Safety of TEV-48125 When Subcutaneously Self-administered in Migraine Patients at the Trial Site and at Home

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.