A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment: TEV-48125
|
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.
|
Outcome Measures
Primary Outcome Measures
- 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. 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 [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sendai Zutsu No-Shinkei Clinic | Sendai | Japan |
Sponsors and Collaborators
- Otsuka Pharmaceutical Co., Ltd.
Investigators
- Study Director: Takehisa Matsumaru, Otsuka Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
More Information
Publications
None provided.- 406-102-00005
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Treatment: TEV-48125 |
|---|---|
| Arm/Group Description | 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). |
| Period Title: Overall Study | |
| STARTED | 71 |
| COMPLETED | 71 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Treatment: TEV-48125 |
|---|---|
| Arm/Group Description | 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). |
| Overall Participants | 71 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
45.9
(10.2)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
55
77.5%
|
| Male |
16
22.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Japanese |
71
100%
|
| Region of Enrollment (Count of Participants) | |
| Japan |
71
100%
|
Outcome Measures
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set: subjects who have received at least 1 dose of the IMP |
| Arm/Group Title | Self-administration at Trial Site | Self-administration at Home |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 71 | 71 |
| Count of Participants [Participants] |
18
25.4%
|
26
NaN
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set: subjects who have received at least 1 dose of the IMP |
| Arm/Group Title | Self-administration at Trial Site | Self-administration at Home |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 71 | 71 |
| Reported as 0 |
71
100%
|
70
NaN
|
| Reported as 1 |
0
0%
|
1
NaN
|
| Reported as 2 |
0
0%
|
0
NaN
|
| Reported as 3 |
0
0%
|
0
NaN
|
| Reported as 4 |
0
0%
|
0
NaN
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set: subjects who have received at least 1 dose of the IMP |
| Arm/Group Title | Self-administration at Trial Site | Self-administration at Home |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 71 | 71 |
| Reported as 0 |
58
81.7%
|
48
NaN
|
| Reported as 1 |
12
16.9%
|
20
NaN
|
| Reported as 2 |
1
1.4%
|
3
NaN
|
| Reported as 3 |
0
0%
|
0
NaN
|
| Reported as 4 |
0
0%
|
0
NaN
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set: subjects who have received at least 1 dose of the IMP |
| Arm/Group Title | Self-administration at Trial Site | Self-administration at Home |
|---|---|---|
| Arm/Group Description | 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). | 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). |
| Measure Participants | 71 | 71 |
| Reported as "Yes" |
71
100%
|
70
NaN
|
| Reported as "No" |
0
0%
|
1
NaN
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set: subjects who have received at least 1 dose of the IMP |
| Arm/Group Title | Treatment: TEV-48125 |
|---|---|
| Arm/Group Description | 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). |
| Measure Participants | 71 |
| Number [deficiencies with the AI device] |
1
|
Adverse Events
| Time Frame | Baseline (Day 1) up to end of treatment (Day 57) | |
|---|---|---|
| Adverse Event Reporting Description | Safety Set: subjects who have received at least 1 dose of the IMP | |
| Arm/Group Title | Treatment: TEV-48125 | |
| Arm/Group Description | 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). | |
All Cause Mortality |
||
| Treatment: TEV-48125 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/71 (0%) | |
Serious Adverse Events |
||
| Treatment: TEV-48125 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/71 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Treatment: TEV-48125 | ||
| Affected / at Risk (%) | # Events | |
| Total | 33/71 (46.5%) | |
| Blood and lymphatic system disorders | ||
| Lymphadenitis | 1/71 (1.4%) | |
| Eye disorders | ||
| Glaucomatocyclitic crises | 1/71 (1.4%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/71 (1.4%) | |
| Vomiting | 1/71 (1.4%) | |
| General disorders | ||
| Injection site erythema | 18/71 (25.4%) | |
| Injection site haemorrhage | 3/71 (4.2%) | |
| Injection site induration | 11/71 (15.5%) | |
| Injection site pain | 6/71 (8.5%) | |
| Injection site pruritus | 4/71 (5.6%) | |
| Injection site swelling | 1/71 (1.4%) | |
| Injection site warmth | 1/71 (1.4%) | |
| Pyrexia | 2/71 (2.8%) | |
| Hepatobiliary disorders | ||
| Gallbladder polyp | 1/71 (1.4%) | |
| Hepatic steatosis | 1/71 (1.4%) | |
| Infections and infestations | ||
| Nasopharyngitis | 2/71 (2.8%) | |
| Tinea pedis | 1/71 (1.4%) | |
| Tonsillitis | 1/71 (1.4%) | |
| Injury, poisoning and procedural complications | ||
| Hand fracture | 1/71 (1.4%) | |
| Heat stroke | 1/71 (1.4%) | |
| Investigations | ||
| Liver function test abnormal | 1/71 (1.4%) | |
| Liver function test increased | 1/71 (1.4%) | |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 1/71 (1.4%) | |
| Nervous system disorders | ||
| Hypoaesthesia | 1/71 (1.4%) | |
| Reproductive system and breast disorders | ||
| Menstruation irregular | 1/71 (1.4%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Oropharyngeal pain | 1/71 (1.4%) | |
| Skin and subcutaneous tissue disorders | ||
| Acne | 1/71 (1.4%) | |
| Miliaria | 1/71 (1.4%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Director of Clinical Trials |
|---|---|
| Organization | Otsuka Pharmaceutical Co., LTD. |
| Phone | +81-3-6361-7366 |
| CL_OPCJ_RDA_Team@otsuka.jp |
- 406-102-00005