Safety Study of Oral Edaravone Administered in Subjects With ALS

Brief Title

Safety Study of Oral Edaravone Administered in Subjects With ALS

Official Title

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Frequency and incidence of Treatment Emergency Adverse Events


Condition

ALS

Intervention

MT-1186

Study Arms / Comparison Groups

 MT-1186
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

150

Start Date

November 18, 2019

Completion Date

November 2021

Primary Completion Date

November 2021

Eligibility 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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Head of Clinical Development,, please email:, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04165824

Organization ID

MT-1186-A01


Responsible Party

Sponsor

Study Sponsor

Mitsubishi Tanabe Pharma Development America, Inc.


Study Sponsor

Head of Clinical Development,, Study Director, Mitsubishi Tanabe Pharma Development America, Inc.


Verification Date

August 2020