Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04165824
Other study ID # MT-1186-A01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04948645 - A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis Phase 1
Completed NCT02405182 - MRI Biomarkers in ALS
Completed NCT00696332 - Talampanel for Amyotrophic Lateral Sclerosis (ALS) Phase 2
Recruiting NCT03865420 - Amyotrophic Lateral Sclerosis (ALS) Families Project
Terminated NCT04054141 - rTMS in Treatment of Spasticity N/A
Recruiting NCT03272503 - A Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Completed NCT05568615 - Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS Phase 3
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Active, not recruiting NCT04259255 - Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)
Recruiting NCT02495571 - Assessment of Voluntary and Reflex Cough in Patients With ALS N/A
Completed NCT02525471 - A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS) Phase 1
Recruiting NCT05031351 - NF-κB Inhibition in Amyotrophic Lateral Sclerosis Phase 2
Active, not recruiting NCT05581771 - Factors Associated With Success of NIPPV in ALS Patients
Active, not recruiting NCT03268603 - Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS) Phase 2
Recruiting NCT05271435 - Digital Tools for Assessment of Motor Functions and Falls in ALS
Completed NCT06005506 - National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function. N/A
Recruiting NCT04138095 - Virtual Reality as an Adjunct to Management of Pain and Anxiety in Palliative Care N/A
Recruiting NCT03698149 - ECoG BMI for Motor and Speech Control N/A
Not yet recruiting NCT05621213 - Satisfaction of Patients With Amyotrophic Lateral Sclerosis Regarding Home Assisted Teleconsultation N/A
Terminated NCT03373981 - Non-invasive Brain Stimulation for the Treatment of Depression Symptoms in ALS N/A