drugset / Trial / NCT01486849

Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT01486849

Phase 2 Completed 27 enrolled Cytokinetics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Phase II, double-blind, randomized, placebo-controlled ascending dose titration study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of multiple ascending doses of CK-2017357 to an individual patient maximum tolerated dose (MTD), using a within-patient twice daily (BID) dose-titration regimen in ALS patients on 50 mg riluzole once daily (QD).

Timeline

Start
2011-11
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject tirasemtiv Other / unclassified 250 mg Oral
Background Riluzole Small molecule 50 mg