Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04577404
Other study ID # MT-1186-A03
Secondary ID 2020-000376-38
Status Completed
Phase Phase 3
First received
Last updated
Start date October 29, 2020
Est. completion date August 8, 2023

Study information

Verified date October 2023
Source Mitsubishi Tanabe Pharma America Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date August 8, 2023
Est. primary completion date August 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subjects must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study. 2. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements. 3. Subjects who successfully completed Study MT-1186-A01 Exclusion Criteria: 1. Subjects of childbearing potential unwilling to use a highly effective method of contraception from Visit 1 until 3 months after the last dose of study medication. 2. Subjects who have a significant risk of suicide. 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 C-SSRS at Visit 3. Subjects who are not eligible to continue in the study, as judged by the Investigator. 4. Subjects who are unable to take their medications orally or through a PEG/RIG tube.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MT-1186
Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.

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 Centre Hospitalier Esquirol Limoges Marcland
France CHU-Nice - Hopital Pasteur 2 Nice Cedex 1
France Hopital Pierre Wertheimer - Hopital Neurologique Paris
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 Lombardia
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 Chibahigashi National Hospital Chiba-shi Chiba
Japan Tokyo Metropolitan Neurological Hospital Fuchu-city Tokyo
Japan Murakami Karindoh Hospital Fukuoka-city Fukuoka
Japan Kansai Electric Power Hospital Recruiting Fukushima-ku, Osaka-shi Osaka
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 Aichi Medical University Hospital Nagakute-shi, Aichi
Japan Niigata University Medical And Dental Hospital Niigata-shi Niigata
Japan Toho University Omori Medical Center Ota-ku Tokyo
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 Emory University - School of Medicine Atlanta Georgia
United States University of Colorado Anschutz Medical Campus Aurora Colorado
United States Johns Hopkins University School of Medicine Baltimore Maryland
United States Wesley Neurology Clinic, P.C. Cordova Tennessee
United States Texas Neurology, PA Dallas Texas
United States UF Health Cancer Center Gainesville Florida
United States Penn State Hershey Children's Hospital Hershey Pennsylvania
United States Neurology Associates, P.C - Lincoln Lincoln Nebraska
United States Medical College of Wisconsin Milwaukee Wisconsin
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 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 from baseline to week 96 ALS Functional Rating Scale- Revised (ALSFRS-R). The ALSFRS-R is rating scale (ratings 0 = can't do, to 4 = normal ability) used to determine participants' assessment of their capability and independence in 12 functional activities. Baseline to Week 96
Other Time (days) to death, tracheostomy, or permanent assisted mechanical ventilation (>= 23 hours/day) Baseline to Week 96
Primary Safety and tolerability as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs), and treatment-emergent adverse events ([TEAEs]) Baseline to Week 96
See also
  Status Clinical Trial Phase
Completed NCT02365922 - Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL)
Completed NCT01699451 - DNA, Blood and Skin Cell Repository for Research on ALS and Related Neurodegenerative Disorders at Mayo Clinic Florida
Terminated NCT03580616 - Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Completed NCT01884571 - Immunosuppression in Amyotrophic Lateral Sclerosis (ALS) Phase 2
Completed NCT02118805 - Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders
Completed NCT00244244 - A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS Phase 2
Active, not recruiting NCT00420719 - Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS) N/A
Completed NCT02936635 - A Study for Patients Who Completed VITALITY-ALS (CY 4031) Phase 3
Withdrawn NCT04055532 - Biomarkers in Neurodegenerative Diseases
Completed NCT03645031 - Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease N/A
Completed NCT01786603 - Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Completed NCT02559869 - Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis
Completed NCT01592552 - A Biospecimen and Clinical Data Study on Patients for Drug & Biomarker Discovery
Completed NCT00403104 - Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Recruiting NCT02424669 - Neuroinflammation in Amyotrophic Lateral Sclerosis - Mechanisms and Therapeutic Perspectives: a Translational Pilot Study Among ALS Patients N/A
Completed NCT02017912 - Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS Phase 2
Completed NCT01366027 - PRISM Registry: Pseudobulbar Affect Registry Series N/A
Completed NCT00330681 - Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Phase 3
Completed NCT00876772 - Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS) Phase 2/Phase 3
Not yet recruiting NCT06351592 - First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS) Phase 1