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A Study for Patients Who Completed VITALITY-ALS (CY 4031)

NCT02936635 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2021-06-15

Study results available
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Summary

The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv in ALS (CY 4031).

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

tirasemtiv

Oral

Sponsors & Collaborators

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • MD, Cytokinetics · Cytokinetics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-17
Primary Completion
2018-10-26
Completion
2018-10-26

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02936635 on ClinicalTrials.gov