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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2071210117 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) | |
| 2021-003900-42 | EudraCT Number |
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Futility Analysis of parent study MT-1186-A02 was met.
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To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-1186 - Group 1 | Experimental | Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country. |
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| MT-1186 - Group 2 | Experimental | Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-1186 | Drug | Oral edaravone |
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| Measure | Description | Time Frame |
|---|---|---|
| Time From the Randomization Date in Study MT-1186-A02 to at Least a 12-point Decrease in ALSFRS-R or Death, Whichever Happens First. | The ASLFRS-R is Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised. The ALSFRS-R measures 12 aspects of physical function, ranging from one's ability to swallow and use utensils to climbing stairs and breathing. Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. | Up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Combined Assessment of Function and Survival (CAFS) Score at All Visits From Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04 | CAFS analysis ranks clinical outcomes on the basis of survival time and change in the ALS Functional Rating Scale-Revised (ALSFRS-R) score. A subject's score will be calculated by comparing each subject to every other subject within each treatment group in the study, resulting in a score of +1 if the outcome was better than the subject being compared, -1 if worse, and 0 if the same. The subject's score will then be calculated by summing up their comparison to all of the other subjects within each treatment group in the study as CAFS score. Patients' summary scores are ranked; a higher score indicates a better performance. The score range is from 1 to N, where N is the total sample size. Since CAFS were calculated using the imputed ALSFRS-R scores with multiple imputation method, and the maximum varies for each simulation, 383 is the maximum possible value of full range for measure of dispersion. |
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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 |
|---|---|---|---|---|---|---|
| Woodland Research Northwest, LLC | Rogers | Arkansas | 72758 | United States | ||
| UF Health Cancer Center/Clinical Trials Office |
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| ID | Title | Description |
|---|---|---|
| FG000 | Edaravone 105 mg (Once Daily) | Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country. MT-1186: Oral edaravone |
| FG001 | Edaravone 105 mg (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 29, 2022 | Aug 30, 2024 |
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| Placebo | Drug | Oral |
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| Baseline, Week 72 and Week 96 |
| Change in the Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 Score at All Visits From Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04 | The ALSAQ-40 is a questionnaire that consists of 40 questions/items with 5 discrete scales: physical mobility, activities of daily living and independence, eating and drinking, communication, emotional reactions, ranging from 0 (best health as assessed by the scale) to 100 (worse health as assessed by the measure). | Baseline, Week 72 and Week 96 |
| Change in ALSFRS-R Score at All Visits From Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04 | 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, Week 72, Week 84 and Week 96 |
| Time From the Randomization Date in Study MT-1186-A02 to Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation (≥23 Hours/Day) | Up to 96 weeks |
| Time From the Randomization Date in Study MT-1186-A02 to Death or Permanent Assisted Mechanical Ventilation (>23 Hours/Day) | Up to 96 weeks |
| Time From the Randomization Date in Study MT-1186-A02 to Death | Up to 96 weeks |
| Gainesville |
| Florida |
| 32610-3633 |
| United States |
| Emory University - School of Medicine | Atlanta | Georgia | 30317-2819 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611-2605 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Neurology Associates, P.C - Lincoln | Lincoln | Nebraska | 68506 | United States |
| University Of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Nerve And Muscle Center Of Texas | Houston | Texas | 77019 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| West Virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic | Morgantown | West Virginia | 26506-9180 | United States |
| University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM) | Edmonton | Alberta | T6G 2B7 | Canada |
| Health Science Center Mcmaster University | Hamilton | Ontario | L8P 1H1 | Canada |
| London Health Sciences Centre - University Hospital | London | Ontario | N6A 5A5 | Canada |
| CHU de Quebec-Hopital-Enfant-Jesus | Québec | Quebec | G1J 1Z4 | Canada |
| Universitaetsklinikum Wuerzburg | Würzburg | 97080 | Germany |
| National Hospital Organization Higashinagoya National Hospital | Nagoya | Aichi-ken | 465-8620 | Japan |
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | 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 |
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan |
| National Hospital Organization Iou National Hospital | Kanazawa | Ishikawa-ken | 920-0192 | Japan |
| Kagawa University Hospital | Kita-gun | Kagawa-ken | 761-0793 | 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 Utano National Hospital | Kyoto | Kyoto | 616-8255 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | Niigata | 951-8520 | Japan |
| Kansai Electric Power Hospital | Osaka | Osaka | 553-0003 | Japan |
| National Hospital Organization Osaka Toneyama Medical Center | Toyonaka | Osaka | 560-8552 | Japan |
| National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders | Shizuoka | Shizuoka | 420-8688 | Japan |
| Tokyo Metropolitan Neurological Hospital | Fuchū | Tokyo | 183-0042 | Japan |
| Teikyo University Hospital | Itabashi-ku | Tokyo | 173-8606 | Japan |
| Toho University Omori Medical Center | Ōta-ku | Tokyo | 143-8541 | Japan |
| Saitama Neuropsychiatric Institute | Saitama | 338-8577 | Japan |
| Hanyang University Medical Center | Wangsimni-ro | Seongdong-gu | 04763 | South Korea |
| Chefarzt Muskelzentrum/ALS Clinic Kantonsspital St.Gallen Muskelzentrum/ALS Clinic | Sankt Gallen | 9007 | Switzerland |
Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country.
MT-1186: Oral edaravone
Placebo: Oral
| COMPLETED |
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| NOT COMPLETED |
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The data collected before the first study drug dose administration date in Study MT-1186-A02 will be used as the baseline for statistical analysis in Study MT-1186-A04.
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| ID | Title | Description |
|---|---|---|
| BG000 | Edaravone 105 mg (Once Daily) | Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country. MT-1186: Oral edaravone |
| BG001 | Edaravone 105 mg (on/Off) | Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country. MT-1186: Oral edaravone Placebo: Oral |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Time From the Randomization Date in Study MT-1186-A02 to at Least a 12-point Decrease in ALSFRS-R or Death, Whichever Happens First. | The ASLFRS-R is Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised. The ALSFRS-R measures 12 aspects of physical function, ranging from one's ability to swallow and use utensils to climbing stairs and breathing. Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. | The outcome measure time frame is from the randomization date in Study MT- 1186-A02 to at least a 12-point decrease in ALSFRS-R or death, whichever happened first. | Posted | Mean | 80% Confidence Interval | Month | Up to 96 weeks |
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| Secondary | The Combined Assessment of Function and Survival (CAFS) Score at All Visits From Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04 | CAFS analysis ranks clinical outcomes on the basis of survival time and change in the ALS Functional Rating Scale-Revised (ALSFRS-R) score. A subject's score will be calculated by comparing each subject to every other subject within each treatment group in the study, resulting in a score of +1 if the outcome was better than the subject being compared, -1 if worse, and 0 if the same. The subject's score will then be calculated by summing up their comparison to all of the other subjects within each treatment group in the study as CAFS score. Patients' summary scores are ranked; a higher score indicates a better performance. The score range is from 1 to N, where N is the total sample size. Since CAFS were calculated using the imputed ALSFRS-R scores with multiple imputation method, and the maximum varies for each simulation, 383 is the maximum possible value of full range for measure of dispersion. | One subject randomized to the On/Off treatment group was excluded from this analysis because the subject did not receive any study treatment. | Posted | Mean | Full Range | units on a scale | Baseline, Week 72 and Week 96 |
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| Secondary | Change in the Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 Score at All Visits From Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04 | The ALSAQ-40 is a questionnaire that consists of 40 questions/items with 5 discrete scales: physical mobility, activities of daily living and independence, eating and drinking, communication, emotional reactions, ranging from 0 (best health as assessed by the scale) to 100 (worse health as assessed by the measure). | Those patients reached to Week 72 and Week 96, and conducted ALSAQ-40 assessment. | Posted | Least Squares Mean | Standard Error | Point | Baseline, Week 72 and Week 96 |
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| Secondary | Change in ALSFRS-R Score at All Visits From Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04 | 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. | Those patients reached to Week 72, Week 84 and Week 96, and conducted ALSFRS-R assessment. | Posted | Least Squares Mean | Standard Error | Point | Baseline, Week 72, Week 84 and Week 96 |
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| Secondary | Time From the Randomization Date in Study MT-1186-A02 to Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation (≥23 Hours/Day) | The outcome measure time frame is from Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04. | Posted | Median | 95% Confidence Interval | Month | Up to 96 weeks |
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| Secondary | Time From the Randomization Date in Study MT-1186-A02 to Death or Permanent Assisted Mechanical Ventilation (>23 Hours/Day) | The outcome measure time frame is from Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04. | Posted | Median | 95% Confidence Interval | Month | Up to 96 weeks |
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| Secondary | Time From the Randomization Date in Study MT-1186-A02 to Death | The outcome measure time frame is from Baseline in Study MT-1186-A02 to the End of Study MT-1186-A04. | Posted | Median | 95% Confidence Interval | Month | Up to 96 weeks |
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Up to 50 weeks
All AEs and SAEs that occur from the time written ICF was obtained until the end of the Safety Follow-up Period or the withdrawal of the subject from the study. The All-Causes Mortality time frame is from Day1 to the End of study MT-1186-A04. On the other hand, time frame of Outcome Measure 7 is from Day1 in MT-1186-A02 to the End of study MT-1186-A04. Therefore, the number of participants of death (i.e., "15" and "12") is inconsistent with information in the NA Explanation in Outcome Measure 7.
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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 | Edaravone 105 mg (Once Daily) | Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country. MT-1186: Oral edaravone | 15 | 104 | 33 | 104 | 24 | 104 |
| EG001 | Edaravone 105 mg (on/Off) | Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country. MT-1186: Oral edaravone Placebo: Oral | 12 | 98 | 27 | 98 | 25 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac 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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| COVID-19 pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Catheter site infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Extradural haematoma | Injury, poisoning and procedural complications | 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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| Thermal burn | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Device dislocation | Product Issues | MedDRA 23.0 | Systematic Assessment |
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| Device malfunction | Product Issues | MedDRA 23.0 | Systematic Assessment |
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| Psychiatric symptom | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Oliguria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Urethral stenosis | Renal and urinary 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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| Orthopnoea | 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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| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Respiratory distress | 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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| Gastrostomy | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | General disorders | MedDRA 23.0 | Systematic Assessment |
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| COVID-19 | 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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| Insomnia | Psychiatric 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 | Jan 10, 2024 | Aug 30, 2024 | SAP_001.pdf |
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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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| Male |
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| Black or African American |
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| Asian - Japanese |
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| Asian - Not Japanese |
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| American Indian or Alaska Native |
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| Native Hawaiian or Pacific Islander |
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| Not Reported |
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| Other |
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Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country.
MT-1186: Oral edaravone
Placebo: Oral
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