Study Purpose:
The purpose of this study is to assess the long-term safety and tolerability of reldesemtiv in patients with ALS who have successfully completed dosing in the Phase 3 clinical trial, CY 5031 (also known as COURAGE-ALS)Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Reldesemtiv
Placebo:
No
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
Cytokinetics MD, Scientific Leadership at Cytokinetics
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
Full Study Summary:
CY 5032 is an open-label extension (OLE) study of the selective fast skeletal muscle troponin activator, reldesemtiv, in patients with ALS who finished dosing (through Week 48) in CY 5031 (COURAGE-ALS). Approximately 400 patients from the sites that participated in CY 5031 are expected to be enrolled in the open-label extension, CY 5032.
Following enrollment, patients will continue dosing with reldesemtiv, 300 mg twice a day for a 600 mg total daily dose (TDD) for a period of 48 weeks.
At the end of 48 weeks, patients may transition to a reldesemtiv Managed Access Program (MAP) the treating physician agrees to participate in the program.
Following enrollment, patients will continue dosing with reldesemtiv, 300 mg twice a day for a 600 mg total daily dose (TDD) for a period of 48 weeks.
At the end of 48 weeks, patients may transition to a reldesemtiv Managed Access Program (MAP) the treating physician agrees to participate in the program.
Study Sponsor:
Cytokinetics
Estimated Enrollment:
72
Estimated Study Start Date:
07 / 25 / 2022
Estimated Study Completion Date:
03 / 31 / 2023
Posting Last Modified Date:
04 / 14 / 2023
Date Study Added to neals.org:
07 / 05 / 2022
Minimum Age:
18 Years
Maximum Age:
N/A
Inclusion Criteria:- Able to comprehend and willing to sign an ICF and willing to comply with all study procedures and restrictions for the duration specified in the Schedule of Activities. If non-written consent is given, a Legal Designee of the patient must sign the ICF form.
- Completed dosing in CY 5031
Exclusion Criteria:
- Has taken investigational study drug (other than reldesemtiv) prior to dosing, within 30 days or five half-lives of the prior agent, whichever is greater
- Presence on Day 1 of any medically significant cardiac, pulmonary, gastrointestinal, musculoskeletal, or psychiatric illness that might interfere with the patient's ability to comply with study procedures or that might confound the interpretation of clinical safety or efficacy data.
- Use of a strong cytochrome P450 (CYP) 3A4 inhibitor within 7 days prior to first dose of reldesemtiv in CY 5032 or a strong CYP3A4 inducer within 14 days prior to first dose of reldesemtiv in CY 5032
- Use of a medication that is an OCT1/OCT2 substrate within 7 days prior to first dose of reldesemtiv in CY 5032
- Currently participating in another trial, managed access program, open label extension, early access program, or through the right to try act is receiving an investigational drug or received an investigational drug or device within 30 days (or 5 half-lives for drugs, whichever is longer) prior to Day 1. Patients also cannot be taking outside of a clinical trial certain investigational drugs (which includes drugs, supplements, and nutraceuticals) that are currently being studied or have been studied for the treatment of ALS.
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute
Phoenix, Arizona
85013
United States
University of California Irvine - ALS & Neuromuscular Center
Orange, California
92868
United States
California Pacific Medical Center - Forbes Norris MDA/ALS Research Center
San Francisco, California
94109
United States
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora, Colorado
80045
United States
George Washington Medical Faculty Associates
Washington, District of Columbia
20037
United States
University of Florida
Jacksonville, Florida
32209
United States
Mayo Clinic Jacksonville
Jacksonville, Florida
32224
United States
University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
Tampa, Florida
33612
United States
Indiana University IU Health Neuroscience Center
Indianapolis, Indiana
43202
United States
The University of Kansas Medical Center
Kansas City, Kansas
66160
United States
Johns Hopkins Outpatient Center
Baltimore, Maryland
21287
United States
Michigan Medicine
Ann Arbor, Michigan
48109
United States
Henry Ford Hospital
Detroit, Michigan
48202
United States
Neurology Associates
Lincoln, Nebraska
68506
United States
Hospital for Special Surgery
New York, New York
10021
United States
SUNY Upstate Medical University Institute for Human Performance
Syracuse, New York
13210
United States
Atrium Health Neuroscience Institute
Charlotte, North Carolina
28207
United States
Cleveland Clinic
Cleveland, Ohio
44195
United States
Texas Neurology, P.A.
Dallas, Texas
75206
United States
Virginia Commonwealth University
Henrico, Virginia
23233
United States
Froedtert Hospital - Department of Neurology
Milwaukee, Wisconsin
53226
United States
Concord Repatriation General Hospital
Concord, New South Wales
2139
Australia
The Perron Institute
Nedlands 6009
Australia
Royal Brisbane and Women's Hospital, Neurology Department
Herston, Queensland
4029
Australia
Uz Leuven Gasthuisberg Department of Neurology
Leuven 3000
Belgium
Sunnybrook Health Sciences Centre
Toronto, Ontario
M4N 3M5
Canada
CHU de Quebec-Universite Laval
Quebec G1J1Z4
Canada
University of Saskatchewan
Saskatoon, Saskatchewan
S7K0M7
Canada
Montreal Neurological Institute and Hospital
Montréal, Quebec
H3A 2B4
Canada
Ottawa Hospital Research Institute
Ottawa, Ontario
K1Y4E9
Canada
McMaster University
Hamilton, Ontario
L8N4K1
Canada
Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick
E3B 0C7
Canada
University of Alberta
Edmonton, Alberta
T6G1Z1
Canada
University of Calgary - Heritage Medical Research Clinic
Calgary, Alberta
T2N 4Z6
Canada
RSCI Education and Research Center Beaumount Hospital
Dublin 9
Ireland
IRCCS Istituto Auxologico Italiano Ospedale San Luca U.O. Neurologia e Stroke Unit
Milan 20149
Italy
AOU Citta della Salute e della Scienza di Torino Universita degli Studi di Torino P.O. Mollinette - Dipartimento de Neuroscienze "Rita Levi Montalcini"
Torino 10126
Italy
UMC Utrecht Department of Neurology, ALS Center
Utrecht 3584
Netherlands
Hospital San Rafael
Madrid 28016
Spain
Hospital Universitario y Politecnico La Fe
Valencia 46026
Spain
Studieenheten, Akademiskt Specialistcentrum
Stockholm 113 61
Sweden