A Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)

Phase 2 Completed 49 enrolled Cytokinetics

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study will generate data on safety, tolerability and pharmacokinetics after multiple daily doses of CK-2017357 in patients with ALS. Patients will be randomized into one of four different treatment groups, receiving daily oral doses of either placebo, 125 mg, 250 mg, or 375 mg of CK-2017357 for 14 days.

Timeline

Start: 2011-06
Primary completion: 2012-03
Completion: 2012-03

Publications

Results Shefner JM, Watson ML, Meng L, Wolff AA; Neals/Cytokinetics STUDY Team. A study to evaluate safety and tolerability of repeated doses of tirasemtiv in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2013 Dec;14(7-8):574-81. doi: 10.3109/21678421.2013.822517. Epub 2013 Aug 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	tirasemtiv	Other / unclassified	125 mg	Oral
Subject	tirasemtiv	Other / unclassified	250 mg	Oral
Subject	tirasemtiv	Other / unclassified	375 mg	Oral
Background	Riluzole 50 MG	Unknown	50 mg	—

A Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)

Summary

Timeline

Publications

Drugs

Indications