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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000376-38 | EudraCT Number | ||
| jRCT2041200084 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) |
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This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-1186 | Experimental | Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-1186 | Drug | Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Events of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESEAs, TEAEs Leading to Discontinuation, Any TEAEs Leading to Death | AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized.
| up to 96 Weeks |
| Number of Subjects of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized. | up to 96 Weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of ALS Functional Rating Scale-Revised (ALSFRS-R) at Week 96 | ALS Functional Rating Scale- Revised (ALSFRS-R). 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. | Baseline to Week 96 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Head of Medical Science | Tanabe Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center | Phoenix | Arizona | 85013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40485494 | Result | Genge A, Pattee GL, Sobue G, Aoki M, Yoshino H, Couratier P, Lunetta C, Petri S, Selness D, Todorovic V, Sasson N, Hirai M, Takahashi F, Salah A, Apple S, Wamil A, Kalin A, Jackson CE. Safety Extension Study of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis for up to an Additional 96 Weeks of Treatment. Muscle Nerve. 2025 Sep;72(3):450-454. doi: 10.1002/mus.28451. Epub 2025 Jun 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MT-1186 | MT-1186 105mg (2 weeks On/Off) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jul 27, 2021 | Jul 29, 2024 |
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Single Arm Open Label
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|
| Number of Events of Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation |
| up to 96 Weeks |
| Neuromuscular Research Center | Phoenix | Arizona | 85028 | United States |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | United States |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| UF Health Cancer Center | Gainesville | Florida | 32610-3633 | United States |
| Emory University - School of Medicine | Atlanta | Georgia | 30317-2819 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21209 | United States |
| Neurology Associates, P.C - Lincoln | Lincoln | Nebraska | 68506 | United States |
| Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation | Winston-Salem | North Carolina | 27157 | United States |
| Penn State Hershey Children's Hospital | Hershey | Pennsylvania | 17025 | United States |
| Alleghany General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Texas Neurology, PA | Dallas | Texas | 75214 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Heritage Medical Research Clinic - University Of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM) | Edmonton | Alberta | T6G 2B7 | Canada |
| Montreal Neurological Institute and Hospital | Montreal | Quebec | H3A 2B4 | Canada |
| CHU-Nice - Hopital Pasteur 2 | Nice | Cedex 1 | 06001 | France |
| Centre Hospitalier Esquirol | Limoges | Marcland | 87025 | France |
| Centre Hospitalier Universitaire (CHU) de Bordeaux | Bordeaux | 33400 | France |
| Hopital Pierre Wertheimer - Hopital Neurologique | Paris | 75013 | France |
| Deutsche Klinik fuer Diagnostik | Wiesbaden | Hesse | 65191 | Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele) | Milan | Lombardy | 20132 | Italy |
| Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA) | Turin | Piedmont | 10126 | Italy |
| Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre) | Milan | 20162 | Italy |
| Aichi Medical University Hospital | Nagakute-shi | Aichi-ken | 480-1195 | Japan |
| National Hospital Organization Chibahigashi National Hospital | Chiba | Chiba | 260-8712 | Japan |
| Murakami Karindoh Hospital | Fukuoka | Fukuoka | 819-8585 | Japan |
| Fukushima Medical University Hospital | Fukushima | Fukushima | 960-1295 | Japan |
| National Hospital Organization Hokkaido Medical Center | Sapporo | Hokkaido | 063-0005 | Japan |
| National Hospital Organization Iou National Hospital | Kanazawa | Ishikawa-ken | 920-0192 | Japan |
| Kagawa University Hospital | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| Kitasato University Hospital | Sagamihara | Kanagawa | 252-0375 | Japan |
| Yokohama City University Hospital | Yokohama | Kanagawa | 236-0004 | Japan |
| National Hospital Organization Kumamoto Saishun Medical Center | Koshi-shi | Kumamoto | 861-1196 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Niigata University Medical And Dental Hospital | Niigata | Niigata | 951-8520 | Japan |
| Kansai Electric Power Hospital Recruiting | Fukushima-ku, Osaka-shi | Osaka | 553-0003 | Japan |
| National Hospital Organization Toneyama Medical Center | Toyonaka-shi | Osaka | 560-8552 | Japan |
| Shiga University of Medical Science Hospital | ÅŒtsu | Shiga | 520-2192 | Japan |
| National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders | Shizuoka | Shizuoka | 420-8688 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Tokyo Metropolitan Neurological Hospital | Fuchū | Tokyo | 183-0042 | Japan |
| Toho University Omori Medical Center | ÅŒta-ku | Tokyo | 143-8541 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MT-1186 | MT-1186 105mg (2 weeks 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 | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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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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| 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 Events of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESEAs, TEAEs Leading to Discontinuation, Any TEAEs Leading to Death | AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized.
| Posted | Number | events | up to 96 Weeks |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized. | Posted | Count of Participants | Participants | up to 96 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline of ALS Functional Rating Scale-Revised (ALSFRS-R) at Week 96 | ALS Functional Rating Scale- Revised (ALSFRS-R). 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 | Baseline to Week 96 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Events of Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation | Not Posted | up to 96 Weeks | Participants |
up to 96 weeks
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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 (2 weeks On/Off) | 19 | 124 | 52 | 124 | 70 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Assisted suicide | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 23.0 | Systematic Assessment |
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| Myocarditis | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Ileus paralytic | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Aerophagia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
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| Accidental death | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Gastrostomy | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
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| Device malfunction | Product Issues | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma America, Inc. | 908-607-1980 | information.US@mb.tanabe-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2023 | Jul 29, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
|
| Number of TESAEs |
|
| Number of TEAEs leading to discontinuation |
|
| Number of TEAEs leading to death |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Number of TEAEs |
| |||||
| Number of ADRs |
| |||||
| Number of severe TEAEs |
| |||||
| Number of TESEAs |
| |||||
| Number of TEAEs leading to discontinuation |
| |||||
| Number of TEAEs leading to death |
|