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Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (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: NCT04577404
Recruitment Status : Active, not recruiting
First Posted : October 6, 2020
Last Update Posted : May 15, 2023
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma America Inc.

Study Description
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Brief Summary:
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: MT-1186 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Arm Open Label
Masking: None (Open Label)
Primary Purpose: Treatment
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

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
Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period
 Drug: MT-1186
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. 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.

  2. Time (days) to death, tracheostomy, or permanent assisted mechanical ventilation (>= 23 hours/day) [ Time Frame: Baseline to Week 96 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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:

  1. 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.
  2. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
  3. Subjects who successfully completed Study MT-1186-A01

Exclusion Criteria:

  1. 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.
  2. 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
  3. Subjects who are not eligible to continue in the study, as judged by the Investigator.
  4. Subjects who are unable to take their medications orally or through a PEG/RIG tube.
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): NCT04577404


Locations
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Sponsors and Collaborators
Mitsubishi Tanabe Pharma America Inc.
Investigators
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Study Director: Head of Medical Science Mitsubishi Tanabe Pharma America Inc.
More Information
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Responsible Party: Mitsubishi Tanabe Pharma America Inc.
ClinicalTrials.gov Identifier: NCT04577404    
Other Study ID Numbers: MT-1186-A03
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
 Proteostasis Deficiencies
Metabolic Diseases
Edaravone
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs