Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT02936635
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02936635
Study Brief:
Protocol Section:
NCT02936635