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

Migraine Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355117
• Other study ID #: 406-102-00005
• Status: Completed
• Phase: Phase 3
• Start date: June 17, 2020
• Est. completion date: November 11, 2020

Study information

• Verified date: October 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 11, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.
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.

Locations

Country	Name	City	State
Japan	Sendai Zutsu No-Shinkei Clinic	Sendai

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; 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.	[1] Baseline (Day 1) to Day 28, [2] Visit 3 (Day 29) up to end of treatment (Day 57)
Secondary	Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI	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	Baseline (Day 1) and Visit 3 (Day 29)
Secondary	Execution Status of Self-administration - Leakage of Drug Solution on the Skin	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)	Baseline (Day 1) and Visit 3 (Day 29)
Secondary	Subject Compliance With the Self-administration Procedure	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.	Baseline (Day 1) and Visit 3 (Day 29)
Secondary	Number of Deficiencies With the AI Device	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.	Baseline (Day 1) and Visit 3 (Day 29)