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Safety 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: NCT04165824
Recruitment Status : Active, not recruiting
First Posted : November 18, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Development America, Inc.

Study Description
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Brief Summary:
The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.

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 : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Study of Oral Edaravone Administered in Subjects With ALS
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

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 Drug: MT-1186
  • An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug free period
  • Subsequent treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period. Treatment cycles are every 4 weeks.
Other Name: Oral edaravone


Outcome Measures
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Primary Outcome Measures :
  1. Frequency and incidence of Treatment Emergency Adverse Events [ Time Frame: up to 48 Weeks ]

Other Outcome Measures:
  1. Change in ALS Functional Rating Scale - Revised from baseline [ Time Frame: up to 48 Weeks ]
  2. Time to event (death, tracheostomy, and permanent assisted mechanical ventilation) [ Time Frame: up to 48 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects will be male or female, ≥ 18 to 75 years of age at the time the ICF is signed
  • Subjects will be diagnosed with Definite ALS, Probable ALS, Probable laboratory-supported ALS, or Possible ALS according to the El Escorial revised criteria for the diagnosis of ALS.
  • Subjects will be living and functioning independently (eg, able to eat, excrete, ambulate independently without assistance of others). The use of supportive tools and adaptive utensil is allowed
  • Subjects will have a baseline forced vital capacity percentage (%FVC) ≥ 70%.
  • Subjects whose first symptom of ALS occurred within 3 years of the time of providing written informed consent.

Exclusion Criteria:

  • Subjects who have the presence or history of any clinically significant disease (except ALS) that could interfere with the objectives of the study (the assessment of safety and efficacy) or the safety of the subject, as judged by the Investigator.
  • Subjects of childbearing potential unwilling to use acceptable method of contraception from the screening visit until 3 months after the last dose of study medication. Subjects who are sexually active who do not agree to use contraception during the study period.
  • Subjects who are female and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1).
  • Subjects who have a significant risk of suicidality. 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 Columbia-Suicide Severity Rating Scale (C-SSRS) within the 3 months before the screening visit.
  • Subjects who have ALT or AST elevations greater than 2 times the ULN at screening.
  • Subjects with a Glomerular Filtration Rate (GFR) <30 mL/Min Per 1.73 m2.
  • Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites.
  • Subjects with hereditary fructose intolerance.
  • Subjects who participated in another study and were administered an investigational product within 1 month or 5 half-lives of the investigational agent, whichever is longer before providing informed consent for the present study.
  • Subjects who are unable to take their medications orally.
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): NCT04165824


Locations
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Sponsors and Collaborators
Mitsubishi Tanabe Pharma Development America, Inc.
Investigators
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Study Director: Head of Medical Science, Mitsubishi Tanabe Pharma Development America, Inc.
More Information
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Responsible Party: Mitsubishi Tanabe Pharma Development America, Inc.
ClinicalTrials.gov Identifier: NCT04165824    
Other Study ID Numbers: MT-1186-A01
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
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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Edaravone
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs