ALS Amyotrophic Lateral Sclerosis
Conditions
Interventions
300 mg reldesemtiv twice daily.
Sponsors
Cytokinetics
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Able to comprehend and willing to sign an Informed Consent Form (ICF). If the patient is able to comprehend, but non-written consent is given, an impartial witness must sign the ICF form • Completed dosing in CY 5031
Exclusion criteria
Exclusion criteria: • Has taken an investigational study drug (other than reldesemtiv) prior to dosing, within 30 days or five half-lives of the prior agent, whichever is greater. When during the study the liver and/or kidney function tests rise to above 3x ULN, the medication intake will be stopped permanently.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events (AEs) in the patient population | — |
Secondary
| Measure | Time frame |
|---|---|
| • Time to the first occurrence of respiratory insufficiency (defined as tracheostomy for any reason or the use of non-invasive ventilation (NIV) for >=22 hours per day for >=10 consecutive days) or death from date of randomization in CY 5031 through Week 48 of CY 5032 • Time to the first hospitalization from Day 1 in CY 5031 through Week 48 of CY 5032 • Combined assessment of change in ALSFRS-R total score, time to onset of respiratory insufficiency, and survival time from baseline of CY 5031 through Week 48 of CY 5032 and from Week 24 of CY 5031 through Week 48 of CY 5032 • Changes in ALS Functional Rating Scale - Revised (ALSFRS-R) total score from baseline of CY 5031 through Week 48 of CY 5032 and from Week 24 of CY 5031 through Week 48 of CY 5032 • Slopes of the changes in ALSFRS-R total score from baseline of CY 5031 through Week 48 of CY 5032 and from Week 24 of CY 5031 through Week 48 of CY 5032 | — |
Countries
Netherlands
Outcome results
None listed