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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2041220069 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) |
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The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. This study will be continued until the earlier date when oral edaravone is commercially available at each site in Japan or August 2023.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-1186 orally | Experimental | Subjects receive the edaravone oral suspension orally once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-1186 | Drug | Suspension |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With AEs and Adverse Drug Reactions | Adverse Event (AE) is classified as treatment emergent if it newly occurred after the first dose of investigational product or if a pre-dose event increases in severity following the first dose of investigational product. Adverse Drug Reaction (ADR) is a noxious and unintended response to a medicinal product that occurs at doses normally used for prophylaxis, diagnosis, or therapy of disease. | up to 8 months |
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| Measure | Description | Time Frame |
|---|---|---|
| ALSFRS-R Total Score | The ALSFRS-R is rating scale (ratings 0 = can't do, to 4 = normal ability) used to determine participants' assessment of their capability and independence in 12 functional activities. | up to 10 months or 31/Aug/2023 |
| Number of Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation (≥23 Hours/Day) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital Organization Higashinagoya National Hospital | Nagoya | Aichi-ken | 465-8620 | Japan | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | MT-1186 | MT-1186 105mg (2weeks On/Off) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | MT-1186 | MT-1186 105mg (2weeks On/Off) |
| 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 Patients With AEs and Adverse Drug Reactions | Adverse Event (AE) is classified as treatment emergent if it newly occurred after the first dose of investigational product or if a pre-dose event increases in severity following the first dose of investigational product. Adverse Drug Reaction (ADR) is a noxious and unintended response to a medicinal product that occurs at doses normally used for prophylaxis, diagnosis, or therapy of disease. | Posted | Count of Participants | Participants | up to 8 months |
|
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up to 8 months
This study was a single arm open-label study including the following one single set of dosing regimen specified in the study protocol: 28 days per cycle, study drugs were received for 10 days in the first 2 weeks and subsequently were not received for the rest 2 weeks. The dosing regimen was not divided into Treatment Period or Drug-Free Period since this was a single arm study. Therefore, AE were not collected respectively per specific intervention in this study.
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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 | MT-1186 | MT-1186 105mg (2weeks On/Off) | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia aspiration | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis externa | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | Please email | cti-inq-ml.JP@ml.tanabe-pharma.com |
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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 | Jun 9, 2022 | Jun 10, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2023 | Jun 10, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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| up to 10 months or 31/Aug/2023 |
| National Hospital Organization Chibahigashi National Hospital |
| Chiba |
| Chiba |
| 260-8712 |
| Japan |
| Fukushima Medical University Hospital | Fukushima | Fukushima | 960-1295 | Japan |
| Kagawa University Hospital | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| Kitasato University Hospital | Sagamihara-shi | Kanagawa | 252-0375 | Japan |
| Yokohama City University Hospital | Yokohama | Kanagawa | 236-0004 | Japan |
| National Hospital Organization Kumamoto Saishun Medical Center | Kōshi | Kumamoto | 861-1196 | Japan |
| National Hospital Organization Osaka Toneyama Medical Center | Toyonaka-shi | Osaka | 560-8552 | Japan |
| Shiga University of Medical Science Hospital | Ōtsu | Shiga | 520-2192 | Japan |
| Tokyo Metropolitan Neurological Hospital | Fuchu-shi | Tokyo | 183-0042 | Japan |
| National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders | Shizuoka | 420-8688 | Japan |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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|
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| Other Pre-specified | ALSFRS-R Total Score | The ALSFRS-R is rating scale (ratings 0 = can't do, to 4 = normal ability) used to determine participants' assessment of their capability and independence in 12 functional activities. | Not Posted | up to 10 months or 31/Aug/2023 | Participants |
| Other Pre-specified | Number of Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation (≥23 Hours/Day) | Not Posted | up to 10 months or 31/Aug/2023 | Participants |
| 15 |
| 2 |
| 15 |
| 5 |
| 15 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Tinea cruris | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Catheter site granuloma | General disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA Version 25.0 | Systematic Assessment |
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| Vital capacity decreased | Investigations | MedDRA Version 25.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Systematic Assessment |
|
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |