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

Completed · Phase 3

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

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).

Key facts

Study ID

NCT02936635

Run by

Cytokinetics

People needed

280

Starts

2016-10-17

Expected to finish

2018-10-26

Last updated by the study team

2021-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to comprehend and willing to sign an Informed Consent Form (ICF). If verbal consent is given, a Legal Designee of the patient must sign the ICF form
• Completed participation on study drug and the Follow-Up Visit in the CY 4031 study
• Male patients, who have not had a vasectomy AND confirmed zero sperm count, must agree for the duration of their participation in the study to either:
• Use a condom during sexual intercourse with female partners who are of childbearing potential AND to have female partners use a highly effective means of contraception OR
• Abstain from sexual intercourse during participation in the study
• Female patients who are not post-menopausal (≥ 1 year) or sterilized, must:
• Not be breastfeeding
• Have a negative pregnancy test
• Have no intention to become pregnant during participation in the study AND
• Practice sexual abstinence, defined as refraining from intercourse during the duration of the study OR if male partners are not vasectomized with a confirmed zero sperm count, require use of a condom AND use of a highly effective contraceptive measure

You may not qualify if…

• Has a diaphragm pacing system (DPS) at study entry or anticipate DPS placement during the course of the study
• Has taken an investigational study drug (other than tirasemtiv) prior to dosing, within 30 days or five half-lives of the prior agent, whichever is greater
• Use of tizanidine and theophylline-containing medications during study participation
• Participation or planning to participate in any form of stem cell therapy for the treatment of ALS or another investigational drug

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California, Irvine — Orange, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Forbes Norris MDA/ALS Research Center — San Francisco, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• University of Colorado Hospital Anschutz Outpatient Pavilion — Aurora, Colorado, United States
• Hospital for Special Care — New Britain, Connecticut, United States
• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of Miami, Miller School of Medicine — Miami, Florida, United States
• Carol & Frank Morsani Center for Advanced Health Care - University of South Florida — Tampa, Florida, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Massachusetts Memorial Medical Center/University of Massachusetts Medical School — Worcester, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• St. Louis University, Department of Neurology & Psychiatry — St Louis, Missouri, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Hospital for Special Surgery — New York, New York, United States
• St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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