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Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Primary Purpose

Amyotrophic Lateral Sclerosis (ALS)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MT-1186
Sponsored by
Mitsubishi Tanabe Pharma America Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
  • Neuromuscular Research Center
  • Woodland Research Northwest
  • University of Colorado Anschutz Medical Campus
  • UF Health Cancer Center
  • Emory University - School of Medicine
  • Johns Hopkins University School of Medicine
  • Neurology Associates, P.C - Lincoln
  • Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation
  • Penn State Hershey Children's Hospital
  • Lewis Katz School of Medicine at Temple University
  • Alleghany General Hospital
  • Wesley Neurology Clinic, P.C.
  • Texas Neurology, PA
  • Medical College of Wisconsin
  • Heritage Medical Research Clinic - University Of Calgary
  • University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
  • Recherche Sepmus, Inc.
  • Montreal Neurological Institute and Hospital
  • CHU-Nice - Hopital Pasteur 2
  • Centre Hospitalier Esquirol
  • Centre Hospitalier Universitaire (CHU) de Bordeaux
  • Hopital Pierre Wertheimer - Hopital Neurologique
  • Deutsche Klinik fuer Diagnostik
  • Medizinische Hochschule Hannover
  • Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
  • Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)
  • Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
  • Aichi Medical University Hospital
  • National Hospital Organization Chibahigashi National Hospital
  • Murakami Karindoh Hospital
  • Fukushima Medical University Hospital
  • National Hospital Organization Hokkaido Medical Center
  • National Hospital Organization Iou National Hospital
  • Kagawa University Hospital
  • Kitasato University Hospital
  • Yokohama City University Hospital
  • National Hospital Organization Kumamoto Saishun Medical Center
  • Tohoku University Hospital
  • Niigata University Medical And Dental Hospital
  • Kansai Electric Power Hospital Recruiting
  • National Hospital Organization Toneyama Medical Center
  • Shiga University of Medical Science Hospital
  • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
  • Juntendo University Hospital
  • Tokyo Metropolitan Neurological Hospital
  • Toho University Omori Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MT-1186

Arm Description

Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period

Outcomes

Primary Outcome Measures

Safety and tolerability as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs), and treatment-emergent adverse events ([TEAEs])

Secondary Outcome Measures

Full Information

First Posted
September 30, 2020
Last Updated
May 12, 2023
Sponsor
Mitsubishi Tanabe Pharma America Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04577404
Brief Title
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Official Title
A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 29, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma America Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis (ALS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Single Arm Open Label
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MT-1186
Arm Type
Experimental
Arm Description
Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period
Intervention Type
Drug
Intervention Name(s)
MT-1186
Other Intervention Name(s)
Oral Edaravone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and tolerability as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs), and treatment-emergent adverse events ([TEAEs])
Time Frame
Baseline to Week 96
Other Pre-specified Outcome Measures:
Title
Change from baseline to week 96
Description
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.
Time Frame
Baseline to Week 96
Title
Time (days) to death, tracheostomy, or permanent assisted mechanical ventilation (>= 23 hours/day)
Time Frame
Baseline to Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements. Subjects who successfully completed Study MT-1186-A01 Exclusion Criteria: 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. 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 Subjects who are not eligible to continue in the study, as judged by the Investigator. Subjects who are unable to take their medications orally or through a PEG/RIG tube.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Head of Medical Science
Organizational Affiliation
Mitsubishi Tanabe Pharma America Inc.
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Neuromuscular Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
Woodland Research Northwest
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UF Health Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-3633
Country
United States
Facility Name
Emory University - School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30317-2819
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Neurology Associates, P.C - Lincoln
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506-2960
Country
United States
Facility Name
Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Facility Name
Penn State Hershey Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17025
Country
United States
Facility Name
Lewis Katz School of Medicine at Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Alleghany General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Wesley Neurology Clinic, P.C.
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Texas Neurology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Heritage Medical Research Clinic - University Of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Recherche Sepmus, Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
CHU-Nice - Hopital Pasteur 2
City
Nice
State/Province
Cedex 1
ZIP/Postal Code
06001
Country
France
Facility Name
Centre Hospitalier Esquirol
City
Limoges
State/Province
Marcland
ZIP/Postal Code
87025
Country
France
Facility Name
Centre Hospitalier Universitaire (CHU) de Bordeaux
City
Bordeaux
ZIP/Postal Code
33400
Country
France
Facility Name
Hopital Pierre Wertheimer - Hopital Neurologique
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Deutsche Klinik fuer Diagnostik
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65191
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
Facility Name
Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)
City
Turin
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
Aichi Medical University Hospital
City
Nagakute-shi,
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
National Hospital Organization Chibahigashi National Hospital
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
Murakami Karindoh Hospital
City
Fukuoka-city
State/Province
Fukuoka
ZIP/Postal Code
819-8585
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
National Hospital Organization Hokkaido Medical Center
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
063-0005
Country
Japan
Facility Name
National Hospital Organization Iou National Hospital
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-0192
Country
Japan
Facility Name
Kagawa University Hospital
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara-city
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
National Hospital Organization Kumamoto Saishun Medical Center
City
Koshi-shi
State/Province
Kumamoto
ZIP/Postal Code
861-1196
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-city
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Niigata University Medical And Dental Hospital
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Kansai Electric Power Hospital Recruiting
City
Fukushima-ku, Osaka-shi
State/Province
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
National Hospital Organization Toneyama Medical Center
City
Toyonaka-shi
State/Province
Osaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Otsu-shi
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
City
Shizuoka-city
State/Province
Shizuoka
ZIP/Postal Code
420-8688
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Tokyo Metropolitan Neurological Hospital
City
Fuchu-city
State/Province
Tokyo
ZIP/Postal Code
183-0042
Country
Japan
Facility Name
Toho University Omori Medical Center
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-8541
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

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