Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
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|ClinicalTrials.gov Identifier: NCT04577404|
Recruitment Status : Active, not recruiting
First Posted : October 6, 2020
Last Update Posted : May 15, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis (ALS)||Drug: MT-1186||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Arm Open Label|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)|
|Actual Study Start Date :||October 29, 2020|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period
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.
Other Name: Oral Edaravone
- Safety and tolerability as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs), and treatment-emergent adverse events ([TEAEs]) [ Time Frame: Baseline to Week 96 ]
- Change from baseline to week 96 [ Time Frame: Baseline to 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.
- Time (days) to death, tracheostomy, or permanent assisted mechanical ventilation (>= 23 hours/day) [ Time Frame: Baseline to Week 96 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study.
- Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
- Subjects who successfully completed Study MT-1186-A01
- Subjects of childbearing potential unwilling to use a highly effective method of contraception from Visit 1 until 3 months after the last dose of study medication.
- Subjects who have a significant risk of suicide. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS at Visit
- Subjects who are not eligible to continue in the study, as judged by the Investigator.
- Subjects who are unable to take their medications orally or through a PEG/RIG tube.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04577404
|Study Director:||Head of Medical Science||Mitsubishi Tanabe Pharma America Inc.|
|Responsible Party:||Mitsubishi Tanabe Pharma America Inc.|
|Other Study ID Numbers:||
2020-000376-38 ( EudraCT Number )
|First Posted:||October 6, 2020 Key Record Dates|
|Last Update Posted:||May 15, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs