Safety Study of Oral Edaravone Administered in Subjects With ALS

ALS Clinical Trial

Official title:

Safety Study of Oral Edaravone Administered in Subjects With ALS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165824
• Other study ID #: MT-1186-A01
• Status: Completed
• Phase: Phase 3
• Start date: November 18, 2019
• Est. completion date: October 7, 2021

Study information

• Verified date: May 2023
• Source: Mitsubishi Tanabe Pharma America Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: October 7, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• ALS

Intervention

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.

Locations

Country	Name	City	State
Canada	Heritage Medical Research Clinic - University Of Calgary	Calgary	Alberta
Canada	University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)	Edmonton	Alberta
Canada	Recherche Sepmus, Inc	Greenfield Park	Quebec
Canada	Montreal Neurological Institute and Hospital	Montreal	Quebec
France	Centre Hospitalier Universitaire (CHU) de Bordeaux	Bordeaux
France	Hopital Pierre Wertheimer - Hopital Neurologique	Bron
France	Centre Hospitalier Esquirol	Limoges	Marcland
France	CHU de NICE Hopital Pasteur 2 -Centre de Reference des Maladies -Neuromusculaires & SLA-Pole Neurosciences Cliniques	Nice cedex 1
France	CHU Nice-Hospital Archet I	Nice cedex 3	Alpes Maritimes
Germany	Medizinische Hochschule Hannover	Hannover	Lower Saxony
Germany	Deutsche Klinik fuer Diagnostik	Wiesbaden	Hessen
Italy	Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)	Milan
Italy	Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)	Milano	MI
Italy	Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)	Turin	Piemonte
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	National Hospital Organization Chiba-East-Hospital	Chiba-shi	Chiba
Japan	Murakami Karindoh Hospital	Fukuoka-city	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima-shi	Fukushima
Japan	National Hospital Organization Iou National Hospital	Kanazawa-shi	Ishikawa
Japan	Kagawa University Hospital	Kita-gun	Kagawa
Japan	National Hospital Organization Kumamoto Saishun Medical Center	Koshi-shi	Kumamoto
Japan	National Hospital Organization Utano Hospital	Kyoto-shi	Kyoto
Japan	Aichi Medical University Hospital	Nagakute-shi	Aichi
Japan	Niigata University Medical And Dental Hospital	Niigata-shi	Niigata
Japan	Shiga University of Medical Science Hospital	Otsu-shi	Shiga
Japan	Kitasato University Hospital	Sagamihara-city	Kanagawa
Japan	National Hospital Organization Hokkaido Medical Center	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital	Sendai-city	Miyagi
Japan	National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders	Shizuoka-city	Shizuoka
Japan	National Hospital Organization Toneyama Medical Center	Toyonaka-shi	Osaka
Japan	Yokohama City University Hospital	Yokohama-shi	Kanagawa
United States	University of Michigan - ALS Center of Excellence	Ann Arbor	Michigan
United States	Emory University - School of Medicine	Atlanta	Georgia
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	Wesley Neurology Clinic, P.C.	Cordova	Tennessee
United States	Texas Neurology, PA	Dallas	Texas
United States	Essentia Institute of Rural Health	Duluth	Minnesota
United States	UF Health Cancer Center	Gainesville	Florida
United States	Penn State Hershey Children's Hospital	Hershey	Pennsylvania
United States	Houston Methodist Neurological Institute	Houston	Texas
United States	Neurology Associates, P.C - Lincoln	Lincoln	Nebraska
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Michigan Health System (UMHS) - Allergy Clinic - Northville Health Center Location	Northville	Michigan
United States	Lewis Katz School of Medicine at Temple University	Philadelphia	Pennsylvania
United States	Neuromuscular Research Center	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center	Phoenix	Arizona
United States	Alleghany General Hospital	Pittsburgh	Pennsylvania
United States	Woodland Research Northwest	Rogers	Arkansas
United States	UT Health Science Center San Antonio	San Antonio	Texas
United States	Sutter Health	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma America Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in ALS Functional Rating Scale - Revised From Baseline		up to 48 Weeks
Other	Time to Event (Death, Tracheostomy, and Permanent Assisted Mechanical Ventilation)		up to 48 Weeks
Primary	Number of Treatment Emergency Adverse Events		up to 48 Weeks
Primary	Number of Participants With Treatment Emergency Adverse Events		Up to 48 Weeks