Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via intravenous drip once a day in patients with ALS whose severity is classified as grade III, based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients who met severity classification III.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCI-186 | Drug | Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks | No primary endpoint was used, because various exploratory analyses were performed. 0=worst; 48=best | baseline and 24 weeks |
| Death or a Specified State of Disease Progression | No primary endpoint was used, because various exploratory analyses were performed. Any of "death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event. | 24 weeks |
| Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks | No primary endpoint was used, because various exploratory analyses were performed. | baseline and 24 weeks |
| Percentage of Participants With Adverse Events | No primary endpoint was used, because various exploratory analyses were performed. | 24 weeks |
| Percentage of Participants With Adverse Drug Reactions | No primary endpoint was used, because various exploratory analyses were performed. | 24 weeks |
| The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients | No primary endpoint was used, because various exploratory analyses were performed. | 24 weeks |
| Percentage of Participants With Abnormal Changes in Sensory Examinations |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Koji Abe, professor | Graduate School of Medicine and Dentistry, Okayama University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28872915 | Result | WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 18 STUDY GROUP. Exploratory double-blind, parallel-group, placebo-controlled study of edaravone (MCI-186) in amyotrophic lateral sclerosis (Japan ALS severity classification: Grade 3, requiring assistance for eating, excretion or ambulation). Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):40-48. doi: 10.1080/21678421.2017.1361441. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MCI-186 | MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min |
| FG001 | Placebo of MCI-186 | MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MCI-186 | MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min |
| BG001 | Placebo of MCI-186 | MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks | No primary endpoint was used, because various exploratory analyses were performed. 0=worst; 48=best | Posted | Least Squares Mean | Standard Error | units on a scale | baseline and 24 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MCI-186 | MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 11.1 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo of MCI-186 | Drug | Two ampoules of Placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles). |
|
No primary endpoint was used, because various exploratory analyses were performed. |
| 24 weeks |
| Patient's convenience |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Death or a Specified State of Disease Progression | No primary endpoint was used, because various exploratory analyses were performed. Any of "death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event. | Posted | Number | events | 24 weeks |
|
|
|
| Primary | Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks | No primary endpoint was used, because various exploratory analyses were performed. | "1 patient with missing value at baseline" was excluded from the FAS in the MCI-186 group. | Posted | Least Squares Mean | Standard Error | percentage of FVC | baseline and 24 weeks |
|
|
|
| Primary | Percentage of Participants With Adverse Events | No primary endpoint was used, because various exploratory analyses were performed. | Posted | Number | percentage of participants | 24 weeks |
|
|
|
| Primary | Percentage of Participants With Adverse Drug Reactions | No primary endpoint was used, because various exploratory analyses were performed. | Posted | Number | percentage of participants | 24 weeks |
|
|
|
| Primary | The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients | No primary endpoint was used, because various exploratory analyses were performed. | Posted | Number | percentage of participants | 24 weeks |
|
|
|
| Primary | Percentage of Participants With Abnormal Changes in Sensory Examinations | No primary endpoint was used, because various exploratory analyses were performed. | A note: Each three patients of both groups did not have data to Staggering due to data missing. Therefore, concerning staggering, the number of participants analysed are 10 in the MCI-186 group and 9 in the placebo of MCI-186 group. | Posted | Number | percentage of participants | 24 weeks |
|
|
|
| 3 |
| 13 |
| 12 |
| 13 |
| EG001 | Placebo of MCI-186 | MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min | 2 | 12 | 12 | 12 |
| Gait disturbance | General disorders | MedDRA 11.1 |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Pelvic venous thrombosis | Vascular disorders | MedDRA 11.1 |
|
| Abnormal sensation in eye | Eye disorders | MedDRA 11.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 |
|
| Dyschezia | Gastrointestinal disorders | MedDRA 11.1 |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 11.1 |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.1 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Toothache | Gastrointestinal disorders | MedDRA 11.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 |
|
| Abasia | General disorders | MedDRA 11.1 |
|
| Feeling cold | General disorders | MedDRA 11.1 |
|
| Gait disturbance | General disorders | MedDRA 11.1 |
|
| Impaired healing | General disorders | MedDRA 11.1 |
|
| Thirst | General disorders | MedDRA 11.1 |
|
| Acarodermatitis | Infections and infestations | MedDRA 11.1 |
|
| Cystitis | Infections and infestations | MedDRA 11.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 |
|
| Oral herpes | Infections and infestations | MedDRA 11.1 |
|
| Pharyngitis | Infections and infestations | MedDRA 11.1 |
|
| Sinusitis | Infections and infestations | MedDRA 11.1 |
|
| Tinea pedis | Infections and infestations | MedDRA 11.1 |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Blood urine present | Investigations | MedDRA 11.1 |
|
| Glucose urine present | Investigations | MedDRA 11.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Headache | Nervous system disorders | MedDRA 11.1 |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA 11.1 |
|
| Tension headache | Nervous system disorders | MedDRA 11.1 |
|
| Anxiety disorder | Psychiatric disorders | MedDRA 11.1 |
|
| Depression | Psychiatric disorders | MedDRA 11.1 |
|
| Insomnia | Psychiatric disorders | MedDRA 11.1 |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
Not provided
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| loss of upper arm function |
|
| tracheotomy |
|
| use of respirator |
|
| use of tube feeding |
|
| Staggering |
|
|
| Vibratory sensation |
|
|