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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
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. This study will be continued until the earlier date when oral edaravone is commercially available at each site in Japan or August 2023.

Condition or disease Intervention/treatment Phase
ALS Drug: MT-1186 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Edaravone

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: MT-1186
Suspension
Other Name: Edaravone


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with AEs and adverse drug reactions [ Time Frame: up to 10 months or 31/Aug/2023 ]

Other Outcome Measures:
  1. 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.

  2. Number of death, tracheostomy, or permanent assisted mechanical ventilation (≥23 hours/day) [ Time Frame: up to 10 months or 31/Aug/2023 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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%).

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Clinical Trials Information Desk '+81-3-5960-9608 cti-inq-ml@ml.mt-pharma.co.jp

Locations
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Japan
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
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: General Manager Mitsubishi Tanabe Pharma Corporation
More Information
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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT05568615    
Other Study ID Numbers: MT-1186-A-301
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

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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
Additional relevant MeSH terms:
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Edaravone
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs