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

• Status: Completed
• Trial end date: 2018-10-26
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cytokinetics

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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