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:
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
Cytokinetics MD / email hidden; JavaScript is required / 650-624-2929
Full Study Summary:
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:
400
Estimated Study Start Date:
07 / 25 / 2022
Estimated Study Completion Date:
12 / 01 / 2024
Posting Last Modified Date:
10 / 25 / 2022
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.
California Pacific Medical Center | Recruiting
San Francisco, California
94109
United States
Mayo Clinic Jacksonville | Recruiting
Megan Donahue / email hidden; JavaScript is required
Jacksonville, Florida
32224
United States
The University of Kansas Medical Center | Recruiting
Kansas City, Kansas
66160
United States
Johns Hopkins Outpatient Center | Recruiting
Baltimore, Maryland
21287
United States
Neurology Associates | Recruiting
Lincoln, Nebraska
68506
United States
Atrium Health Neuroscience Institute | Recruiting
Charlotte, North Carolina
28207
United States
Virginia Commonwealth University | Recruiting
LaVon Smith / email hidden; JavaScript is required
Henrico, Virginia
23233
United States
University of Alberta | Recruiting
Kelsey Tymkow / email hidden; JavaScript is required
Edmonton, Alberta
T6G1Z1
Canada
Stan Cassidy Centre for Rehabilitation | Recruiting
Colleen O'Connell
Shane McCullum / email hidden; JavaScript is required
Fredericton, New Brunswick
E3B 0C7
Canada
McMaster University | Recruiting
Daniela Trapsa / email hidden; JavaScript is required
Hamilton, Ontario
L8N4K1
Canada
Montreal Neurological Institute and Hospital | Recruiting
Montréal, Quebec
H3A 2B4
Canada
University of Saskatchewan | Recruiting
Twyla Bode / email hidden; JavaScript is required
Saskatoon, Saskatchewan
S7K0M7
Canada
CHU de Quebec-Universite Laval | Recruiting
Alexandra Simard / email hidden; JavaScript is required
Quebec G1J1Z4
Canada