Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05151471 |
Recruitment Status :
Terminated
(Futility Analysis of parent study MT-1186-A02 was met.)
First Posted : December 9, 2021
Last Update Posted : October 30, 2023
|
Sponsor:
Mitsubishi Tanabe Pharma America Inc.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma America Inc.
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | November 28, 2021 | ||||
First Posted Date ICMJE | December 9, 2021 | ||||
Last Update Posted Date | October 30, 2023 | ||||
Actual Study Start Date ICMJE | January 11, 2022 | ||||
Actual Primary Completion Date | September 29, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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. [ Time Frame: Up to 96 weeks ] 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.
|
||||
Original Primary Outcome Measures ICMJE |
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. [ Time Frame: Up to 96 weeks ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures |
|
||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS | ||||
Official Title ICMJE | A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS) | ||||
Brief Summary | 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 | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||
Condition ICMJE | ALS | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
202 | ||||
Original Estimated Enrollment ICMJE |
300 | ||||
Actual Study Completion Date ICMJE | September 29, 2023 | ||||
Actual Primary Completion Date | September 29, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, Germany, Japan, Korea, Republic of, Switzerland, United States | ||||
Removed Location Countries | United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT05151471 | ||||
Other Study ID Numbers ICMJE | MT-1186-A04 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Current Responsible Party | Mitsubishi Tanabe Pharma America Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Mitsubishi Tanabe Pharma America Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | Mitsubishi Tanabe Pharma America Inc. | ||||
Verification Date | October 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |