Trial Outcomes & Findings for A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients (NCT NCT04355117)
NCT ID: NCT04355117
Last Updated: 2021-10-28
Results Overview
* 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.
COMPLETED
PHASE3
71 participants
[1] Baseline (Day 1) to Day 28, [2] Visit 3 (Day 29) up to end of treatment (Day 57)
2021-10-28
Participant Flow
Participant milestones
| Measure |
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).
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|---|---|
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Overall Study
STARTED
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71
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Overall Study
COMPLETED
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71
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
Baseline characteristics by cohort
| Measure |
Treatment: TEV-48125
n=71 Participants
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).
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Age, Continuous
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45.9 years
STANDARD_DEVIATION 10.2 • n=93 Participants
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Sex: Female, Male
Female
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55 Participants
n=93 Participants
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Sex: Female, Male
Male
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16 Participants
n=93 Participants
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Race/Ethnicity, Customized
Japanese
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71 Participants
n=93 Participants
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Region of Enrollment
Japan
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71 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: [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
* 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.
Outcome measures
| Measure |
Self-administration at Trial Site
n=71 Participants
Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly at the trial site under the supervision of the investigator (Baseline).
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Self-administration at Home
n=71 Participants
Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly at home (Visit 3).
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Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
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18 Participants
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26 Participants
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Visit 3 (Day 29)Population: Safety Set: subjects who have received at least 1 dose of the IMP
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
Outcome measures
| Measure |
Self-administration at Trial Site
n=71 Participants
Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly at the trial site under the supervision of the investigator (Baseline).
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Self-administration at Home
n=71 Participants
Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly at home (Visit 3).
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Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI
Reported as 2
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0 Participants
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0 Participants
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Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI
Reported as 0
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71 Participants
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70 Participants
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Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI
Reported as 1
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0 Participants
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1 Participants
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Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI
Reported as 3
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0 Participants
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0 Participants
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Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI
Reported as 4
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0 Participants
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0 Participants
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Visit 3 (Day 29)Population: Safety Set: subjects who have received at least 1 dose of the IMP
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)
Outcome measures
| Measure |
Self-administration at Trial Site
n=71 Participants
Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly at the trial site under the supervision of the investigator (Baseline).
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Self-administration at Home
n=71 Participants
Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly at home (Visit 3).
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Execution Status of Self-administration - Leakage of Drug Solution on the Skin
Reported as 0
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58 Participants
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48 Participants
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Execution Status of Self-administration - Leakage of Drug Solution on the Skin
Reported as 1
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12 Participants
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20 Participants
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Execution Status of Self-administration - Leakage of Drug Solution on the Skin
Reported as 2
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1 Participants
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3 Participants
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Execution Status of Self-administration - Leakage of Drug Solution on the Skin
Reported as 3
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0 Participants
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0 Participants
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Execution Status of Self-administration - Leakage of Drug Solution on the Skin
Reported as 4
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0 Participants
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0 Participants
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Visit 3 (Day 29)Population: Safety Set: subjects who have received at least 1 dose of the IMP
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.
Outcome measures
| Measure |
Self-administration at Trial Site
n=71 Participants
Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly at the trial site under the supervision of the investigator (Baseline).
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Self-administration at Home
n=71 Participants
Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly at home (Visit 3).
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Subject Compliance With the Self-administration Procedure
Reported as "Yes"
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71 Participants
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70 Participants
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Subject Compliance With the Self-administration Procedure
Reported as "No"
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0 Participants
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1 Participants
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Visit 3 (Day 29)Population: Safety Set: subjects who have received at least 1 dose of the IMP
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.
Outcome measures
| Measure |
Self-administration at Trial Site
n=71 Participants
Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly at the trial site under the supervision of the investigator (Baseline).
|
Self-administration at Home
Each subject subcutaneously self-administered TEV-48125 at 225 mg/1.5 mL (150 mg/mL) using an autoinjector (AI) once monthly at home (Visit 3).
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Number of Deficiencies With the AI Device
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1 deficiencies with the AI device
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—
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Adverse Events
Treatment: TEV-48125
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment: TEV-48125
n=71 participants at risk
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).
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Blood and lymphatic system disorders
Lymphadenitis
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Eye disorders
Glaucomatocyclitic crises
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Gastrointestinal disorders
Abdominal pain
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Gastrointestinal disorders
Vomiting
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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General disorders
Injection site erythema
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25.4%
18/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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General disorders
Injection site haemorrhage
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4.2%
3/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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General disorders
Injection site induration
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15.5%
11/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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General disorders
Injection site pain
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8.5%
6/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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General disorders
Injection site pruritus
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5.6%
4/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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General disorders
Injection site swelling
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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General disorders
Injection site warmth
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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General disorders
Pyrexia
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2.8%
2/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Hepatobiliary disorders
Gallbladder polyp
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Hepatobiliary disorders
Hepatic steatosis
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Infections and infestations
Nasopharyngitis
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2.8%
2/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Infections and infestations
Tinea pedis
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Infections and infestations
Tonsillitis
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Injury, poisoning and procedural complications
Hand fracture
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Injury, poisoning and procedural complications
Heat stroke
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Investigations
Liver function test abnormal
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Investigations
Liver function test increased
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
|
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Musculoskeletal and connective tissue disorders
Back pain
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
|
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Nervous system disorders
Hypoaesthesia
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
|
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Reproductive system and breast disorders
Menstruation irregular
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
|
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Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
|
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Skin and subcutaneous tissue disorders
Acne
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
|
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Skin and subcutaneous tissue disorders
Miliaria
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1.4%
1/71 • Baseline (Day 1) up to end of treatment (Day 57)
Safety Set: subjects who have received at least 1 dose of the IMP
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Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place