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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 : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Development America, Inc.

Tracking Information
First Submitted Date  ICMJE November 13, 2019
First Posted Date  ICMJE November 18, 2019
Last Update Posted Date September 28, 2021
Actual Study Start Date  ICMJE November 18, 2019
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
Frequency and incidence of Treatment Emergency Adverse Events [ Time Frame: up to 48 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 3, 2020)
  • Change in ALS Functional Rating Scale - Revised from baseline [ Time Frame: up to 48 Weeks ]
  • Time to event (death, tracheostomy, and permanent assisted mechanical ventilation) [ Time Frame: up to 48 Weeks ]
Original Other Pre-specified Outcome Measures
 (submitted: November 13, 2019)
  • Change in ALS Functional Rating Scale - Revised from baseline [ Time Frame: up to 48 Weeks ]
  • Time to event(death, tracheostomy, gastrostomy tube placement and permanent assisted mechanical ventilation) [ Time Frame: up to 48 Weeks ]
 
Descriptive Information
Brief Title  ICMJE Safety Study of Oral Edaravone Administered in Subjects With ALS
Official Title  ICMJE Safety Study of Oral Edaravone Administered in Subjects With ALS
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ALS
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: MT-1186
Intervention: Drug: MT-1186
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 27, 2021)
185
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2019)
150
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (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,   France,   Germany,   Italy,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04165824
Other Study ID Numbers  ICMJE MT-1186-A01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mitsubishi Tanabe Pharma Development America, Inc.
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Development America, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Head of Medical Science, Mitsubishi Tanabe Pharma Development America, Inc.
PRS Account Mitsubishi Tanabe Pharma Development America, Inc.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP