Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05568615|
Recruitment Status : Recruiting
First Posted : October 5, 2022
Last Update Posted : March 23, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|ALS||Drug: MT-1186||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open-label Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With Amyotrophic Lateral Sclerosis (ALS)|
|Actual Study Start Date :||October 26, 2022|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: MT-1186 orally
Subjects receive the edaravone oral suspension orally once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period.
Other Name: Edaravone
- Number of patients with AEs and adverse drug reactions [ Time Frame: up to 10 months or 31/Aug/2023 ]
- ALSFRS-R total score [ Time Frame: up to 10 months or 31/Aug/2023 ]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.
- Number of death, tracheostomy, or permanent assisted mechanical ventilation (≥23 hours/day) [ Time Frame: up to 10 months or 31/Aug/2023 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects must provide a 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 complete Week 96 of Study MT-1186-A03 or Week 48 of Study MT-1186-A04 and have been compliant with study drug (80-120%).
- Subjects of childbearing potential unwilling to use a highly effective method of contraception from the 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 Week 96 of the A03 study or at Week 48 of the A04 study.
- Subjects who are not eligible to continue in the study, as judged by the Investigator.
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): NCT05568615
|Contact: Clinical Trials Information Deskemail@example.com|
|National Hospital Organization Higashinagoya National Hospital||Recruiting|
|Nagoya-shi, Aichi, Japan, 465-8620|
|National Hospital Organization Chibahigashi National Hospital||Recruiting|
|Chiba-shi, Chiba, Japan, 260-8712|
|Fukushima Medical University Hospital||Recruiting|
|Fukushima-shi, Fukushima, Japan, 960-1295|
|Kagawa University Hospital||Recruiting|
|Kita-gun, Kagawa, Japan, 761-0793|
|Kitasato University Hospital||Recruiting|
|Sagamihara-shi, Kanagawa, Japan, 252-0375|
|Yokohama City University Hospital||Recruiting|
|Yokohama-shi, Kanagawa, Japan, 236-0004|
|National Hospital Organization Kumamoto Saishun Medical Center||Recruiting|
|Koshi, Kumamoto, Japan, 861-1196|
|National Hospital Organization Osaka Toneyama Medical Center||Recruiting|
|Toyonaka-shi, Osaka, Japan, 560-8552|
|Shiga University of Medical Science Hospital||Recruiting|
|Otsu-shi, Shiga, Japan, 520-2192|
|Tokyo Metropolitan Neurological Hospital||Recruiting|
|Fuchu-shi, Tokyo, Japan, 183-0042|
|National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders||Recruiting|
|Shizuoka, Japan, 420-8688|
|Study Director:||General Manager||Mitsubishi Tanabe Pharma Corporation|
|Responsible Party:||Mitsubishi Tanabe Pharma Corporation|
|Other Study ID Numbers:||
jRCT2041220069 ( Registry Identifier: Japan Registry of Clinical Trials (jRCT) )
|First Posted:||October 5, 2022 Key Record Dates|
|Last Update Posted:||March 23, 2023|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs