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NCT03160898 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)

A Phase 2 study, sponsored by Cytokinetics.

Completed
Registry status
Phase 2
Development phase
458
Enrollment target

NCT03160898: Completed Phase 2 study, sponsored by Cytokinetics.

NCT03160898 is a Phase 2 study that has completed, run by Cytokinetics. The registered enrollment target is 458 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (244% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03160898, a Phase 2 study, has completed, sponsored by Cytokinetics.

COMPLETED
Registry status
Phase 2
Development phase
458 participants
Enrollment target

Study Summary

The purpose of this study was to assess the effect of CK-2127107 (hereafter referred to as reldesemtiv) versus placebo on respiratory function and other measures of skeletal muscle function in patients with ALS.

Primary Outcome

Slow vital capacity was measured using a spirometer (in units of liters). Following 3 to 5 breaths at rest, patients were instructed to take as deep an inspiration as possible followed by a maximum exhalation (blowing out all the air in their lungs). Values obtained were converted to percent predicted values using the Global Lung Initiative equation (ie, the test result as a percent of predicted values for patients of similar demographic and baseline characteristics \[eg, height, age, sex\]).

Interventions

  • DRUG Placebo
  • DRUG Reldesemtiv

Trial Details

FieldValue
Enrollment Target 458 participants
Start Date 2017-07-24
Est. Completion 2019-03-07
Phase Phase 2
Cytokinetics

31 total trials

What the finished NCT03160898 record still lists

NCT03160898 is an interventional study that assigns participants to a tested intervention. The registered 458 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (244% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03160898 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03160898 about?

NCT03160898 is a clinical study titled "A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)". The purpose of this study was to assess the effect of CK-2127107 (hereafter referred to as reldesemtiv) versus placebo on respiratory function and other measures of skeletal muscle function in patients with ALS.

What is the current status of trial NCT03160898?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 458 participants. The study started on 2017-07-24. Estimated completion is 2019-03-07.

What interventions are being tested in trial NCT03160898?

The interventions under investigation include: Placebo (DRUG), Reldesemtiv (DRUG).

Who is sponsoring clinical trial NCT03160898?

This trial is sponsored by Cytokinetics, which has 31 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03160898's enrollment target sits among peer trials

458 84th of 2000 higher than 1,917 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03160898, the US trial registry maintained by the National Library of Medicine. NCT03160898 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.