Migraine
Conditions
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.
Interventions
DRUGEach 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.
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | [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. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI | 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 |
| Execution Status of Self-administration - Leakage of Drug Solution on the Skin | 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) |
| Subject Compliance With the Self-administration Procedure | 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. |
| Number of Deficiencies With the AI Device | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment: TEV-48125 Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly for a total of 2 doses. The first dose was self-administered at the trial site under the supervision of the investigator (Baseline) and the second dose was self-administered at home (Visit 3). | 71 |
| Total | 71 |
Baseline characteristics
| Characteristic | Treatment: TEV-48125 |
|---|---|
| Age, Continuous | 45.9 years STANDARD_DEVIATION 10.2 |
| Race/Ethnicity, Customized Japanese | 71 Participants |
| Region of Enrollment Japan | 71 Participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 71 |
| other Total, other adverse events | 33 / 71 |
| serious Total, serious adverse events | 0 / 71 |
Outcome results
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. 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.
Time frame: [1] Baseline (Day 1) to Day 28, [2] Visit 3 (Day 29) up to end of treatment (Day 57)
Population: Safety Set: subjects who have received at least 1 dose of the IMP
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-administration at Trial Site | Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | 18 Participants |
| Self-administration at Home | Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | 26 Participants |
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
Time frame: Baseline (Day 1) and Visit 3 (Day 29)
Population: Safety Set: subjects who have received at least 1 dose of the IMP
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self-administration at Trial Site | Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI | Reported as 1 | 0 Participants |
| Self-administration at Trial Site | Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI | Reported as 3 | 0 Participants |
| Self-administration at Trial Site | Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI | Reported as 2 | 0 Participants |
| Self-administration at Trial Site | Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI | Reported as 4 | 0 Participants |
| Self-administration at Trial Site | Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI | Reported as 0 | 71 Participants |
| Self-administration at Home | Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI | Reported as 4 | 0 Participants |
| Self-administration at Home | Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI | Reported as 0 | 70 Participants |
| Self-administration at Home | Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI | Reported as 1 | 1 Participants |
| Self-administration at Home | Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI | Reported as 2 | 0 Participants |
| Self-administration at Home | Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI | Reported as 3 | 0 Participants |
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)
Time frame: Baseline (Day 1) and Visit 3 (Day 29)
Population: Safety Set: subjects who have received at least 1 dose of the IMP
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self-administration at Trial Site | Execution Status of Self-administration - Leakage of Drug Solution on the Skin | Reported as 1 | 12 Participants |
| Self-administration at Trial Site | Execution Status of Self-administration - Leakage of Drug Solution on the Skin | Reported as 3 | 0 Participants |
| Self-administration at Trial Site | Execution Status of Self-administration - Leakage of Drug Solution on the Skin | Reported as 2 | 1 Participants |
| Self-administration at Trial Site | Execution Status of Self-administration - Leakage of Drug Solution on the Skin | Reported as 4 | 0 Participants |
| Self-administration at Trial Site | Execution Status of Self-administration - Leakage of Drug Solution on the Skin | Reported as 0 | 58 Participants |
| Self-administration at Home | Execution Status of Self-administration - Leakage of Drug Solution on the Skin | Reported as 4 | 0 Participants |
| Self-administration at Home | Execution Status of Self-administration - Leakage of Drug Solution on the Skin | Reported as 0 | 48 Participants |
| Self-administration at Home | Execution Status of Self-administration - Leakage of Drug Solution on the Skin | Reported as 1 | 20 Participants |
| Self-administration at Home | Execution Status of Self-administration - Leakage of Drug Solution on the Skin | Reported as 2 | 3 Participants |
| Self-administration at Home | Execution Status of Self-administration - Leakage of Drug Solution on the Skin | Reported as 3 | 0 Participants |
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.
Time frame: Baseline (Day 1) and Visit 3 (Day 29)
Population: Safety Set: subjects who have received at least 1 dose of the IMP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self-administration at Trial Site | Number of Deficiencies With the AI Device | 1 deficiencies with the AI device |
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.
Time frame: Baseline (Day 1) and Visit 3 (Day 29)
Population: Safety Set: subjects who have received at least 1 dose of the IMP
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self-administration at Trial Site | Subject Compliance With the Self-administration Procedure | Reported as Yes | 71 Participants |
| Self-administration at Trial Site | Subject Compliance With the Self-administration Procedure | Reported as No | 0 Participants |
| Self-administration at Home | Subject Compliance With the Self-administration Procedure | Reported as Yes | 70 Participants |
| Self-administration at Home | Subject Compliance With the Self-administration Procedure | Reported as No | 1 Participants |