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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment: TEV-48125 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Takehisa Matsumaru | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sendai Zutsu No-Shinkei Clinic | Sendai | Japan |
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.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) |
| Safety Set: subjects who have received at least 1 dose of the IMP | Posted | Count of Participants | Participants | [1] Baseline (Day 1) to Day 28, [2] Visit 3 (Day 29) up to end of treatment (Day 57) |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2020 | Oct 4, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2020 | Oct 4, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Baseline (Day 1) and Visit 3 (Day 29) |
| 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.
| Baseline (Day 1) and Visit 3 (Day 29) |
| 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) |
| 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) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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). |
| OG001 | 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). |
|
|
| 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.
| Safety Set: subjects who have received at least 1 dose of the IMP | Posted | Count of Participants | Participants | 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.
| Safety Set: subjects who have received at least 1 dose of the IMP | Posted | Count of Participants | Participants | 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. | Safety Set: subjects who have received at least 1 dose of the IMP | Posted | Count of Participants | Participants | 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. | Safety Set: subjects who have received at least 1 dose of the IMP | Posted | Number | deficiencies with the AI device | Baseline (Day 1) and Visit 3 (Day 29) |
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| 33 |
| 71 |
| Glaucomatocyclitic crises | Eye disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA Ver. 23.1 | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| Reported as 2 |
|
| Reported as 3 |
|
| Reported as 4 |
|
| Reported as 2 |
|
| Reported as 3 |
|
| Reported as 4 |
|