Back to resultsA Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
Primary Purpose
Migraine
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
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.
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
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
Sites / Locations
- Sendai Zutsu No-Shinkei Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment: TEV-48125
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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)
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.
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.
Full Information
NCT ID
NCT04355117
First Posted
March 19, 2020
Last Updated
October 26, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04355117
Brief Title
A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
November 11, 2020 (Actual)
Study Completion Date
November 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment: TEV-48125
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
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.
Intervention Description
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 Outcome Measure Information:
Title
Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
Description
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.
Time Frame
[1] Baseline (Day 1) to Day 28, [2] Visit 3 (Day 29) up to end of treatment (Day 57)
Secondary Outcome Measure Information:
Title
Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI
Description
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
Time Frame
Baseline (Day 1) and Visit 3 (Day 29)
Title
Execution Status of Self-administration - Leakage of Drug Solution on the Skin
Description
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)
Time Frame
Baseline (Day 1) and Visit 3 (Day 29)
Title
Subject Compliance With the Self-administration Procedure
Description
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.
Time Frame
Baseline (Day 1) and Visit 3 (Day 29)
Title
Number of Deficiencies With the AI Device
Description
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.
Time Frame
Baseline (Day 1) and Visit 3 (Day 29)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takehisa Matsumaru
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Sendai Zutsu No-Shinkei Clinic
City
Sendai
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
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