Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03160898) enrolled 458 people with ALS (amyotrophic lateral sclerosis, also known as motor neurone disease). Participants were divided into four groups: one group received a placebo (a dummy treatment with no active ingredient), while the other three groups received different doses of a drug called reldesemtiv — either 150 mg, 300 mg, or 450 mg, each taken twice a day. The trial ran for 12 weeks and was primarily measuring changes in lung breathing capacity, specifically a test called "slow vital capacity" (how much air a person can breathe out after taking the deepest breath possible), expressed as a percentage of what would be expected for someone of similar age, height, and sex. The reported data shows that for the main measurement — change in breathing capacity over 12 weeks — all groups showed a decline from their starting point. The placebo group declined by an average of 6.46 percentage points, while the reldesemtiv groups declined by 4.97 (150 mg), 4.62 (300 mg), and 4.58 (450 mg) percentage points respectively. For the secondary measurements, the reported data shows changes in an ALS disability rating scale (scored 0–48, where higher means better function): the placebo group's average score fell by 3.53 points, compared to falls of 2.40, 2.62, and 2.94 points in the three reldesemtiv groups. A third measure tracked the rate of muscle strength change over time — again, all groups showed a decline, with the placebo group declining at a rate of −0.1444 units per day, and the reldesemtiv groups at −0.1198, −0.1299, and −0.0956 units per day respectively. It is worth noting that across all three measures, every group — including those taking reldesemtiv — showed a decline from their starting point over the 12 weeks; the reported numbers simply reflect different amounts of decline between groups. No safety or side-effect data was included in the structured results submitted to ClinicalTrials.gov, so that information is not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 37641579) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Motor Neurone Disease Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with ALS (either inherited or not inherited) within the last 24 months before the screening visit
- Your lung breathing capacity (measured while sitting upright) is at least 60% of what would be expected for someone your age, height, and sex
- You are able to swallow tablets
- You have a caregiver available if you need one
- You are able to complete breathing tests in a consistent and repeatable way
- Your routine blood and lab test results are normal, or if slightly outside normal, a doctor has confirmed this is not a concern
- If you are a male patient who has not had a vasectomy with confirmed zero sperm count, you must agree to use an approved form of contraception or avoid sexual intercourse from your first dose until 10 weeks after your last dose
- If you are a female patient, you must be post-menopausal or surgically sterilised, not breastfeeding, have a negative pregnancy test, not planning to become pregnant, and use approved contraception or avoid heterosexual intercourse from screening until 10 weeks after your last dose
- You have either been taking riluzole (a common ALS medication) for at least 30 days before screening, or you have not taken it for at least 30 days before screening and do not plan to start it during the study
- You have either completed at least 2 full cycles of edaravone (another ALS medication) before screening, or you have not taken it for at least 30 days before screening and do not plan to start it during the study
Who may not be able to join:
- You are already using any breathing support devices (such as CPAP, BiPAP, or a ventilator through a tracheostomy) or supplemental oxygen at the time of screening
- Your neurological problems are caused by a condition other than ALS
- You have a significant heart, lung, digestive, muscle, or mental health condition that could affect your ability to take part or make it harder for researchers to interpret the results
- You have taken part in another clinical trial and received an experimental drug within the last 30 days (or longer, depending on the drug) before starting this study
- You have previously received the experimental drugs CK-2127107 or tirasemtiv in any clinical trial
- You have had or are planning to have stem cell therapy for ALS during the study
- You have had or are planning to have gene therapy for ALS during the study
- You have had or are considering getting a diaphragm pacing system (a device to help with breathing) during the study
- You have had a history of substance abuse in the past 2 years
- You are taking certain medications that may interfere with the study (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: MD Cytokinetics, Cytokinetics
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline to Week 12 in the Percent Predicted Slow Vital Capacity (SVC)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.