Phase 3
Completed N=280
A Study for Patients Who Completed VITALITY-ALS (CY 4031)
Amyotrophic Lateral Sclerosis (ALS)
Source: ClinicalTrials.gov NCT02936635 ↗
Enrolled (actual)
280
Serious AEs
30.4%
Results posted
May 2021
Primary outcomePrimary: Number of Participants With Adverse Events — 112; 157 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
112; 157 | — |
| SECONDARY Change From CY 4031 Baseline in Percent Predicted Slow Vital Capacity to Week 24 in CY 4033 |
-28.79; -32.69 | 0.2821 |
| SECONDARY Change From CY 4031 Baseline in Percent Predicted Slow Vital Capacity to Week 48 in CY 4033 |
-35.55; -40.87 | 0.2118 |
| SECONDARY Change From CY 4031 Baseline in ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score at Week 24 |
-13.78; -14.35 | 0.6354 |
| SECONDARY Change From CY 4031 Baseline in ALSFRS-R Total Score at Week 48 |
-17.61; -17.82 | 0.8887 |
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
Data sourced from ClinicalTrials.gov (NCT02936635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.