Cytokinetics, Incorporated CYTK announced today an amendment to the protocol for BENEFIT-ALS (Blinded
Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv
in ALS). BENEFIT-ALS is a Phase IIb, multinational, double-blind, randomized,
placebo-controlled clinical trial designed to evaluate the safety,
tolerability and potential efficacy of tirasemtiv, a fast skeletal muscle
troponin activator, in patients with amyotrophic lateral sclerosis (ALS). The
primary analysis of BENEFIT-ALS will compare the mean change from baseline in
the ALS Functional Rating Scale in its revised form, or ALSFRS-R (a clinically
validated instrument designed to measure disease progression and changes in
functional status), in patients receiving tirasemtiv versus those receiving
placebo.
Cytokinetics recently announced that it had been informed by its data
management vendor that a programming error in the electronic data capture
system controlling study drug assignment caused 58 patients initially
randomized to and treated with tirasemtiv to receive placebo instead at a
certain study visit and for the remainder of the study. No patients randomized
to placebo were dispensed incorrect treatment. Cytokinetics and all clinical
trial site personnel remain blinded to the specific patients affected by the
error. Following detection of the error, the company took steps to ensure that
no further incorrect study drug assignments occurred and to correct the
programming error in the electronic data capture system controlling study drug
assignment. In addition, the company convened an ad hoc meeting of the study's
Data Safety Monitoring Board (DSMB) to assess whether the error in dispensing
study drug had impacted the safety of the 58 affected patients. After review
of the relevant safety data from BENEFIT-ALS, the DSMB reported no concerns
regarding patient safety.
Following interactions with regulatory authorities, Cytokinetics amended the
protocol for BENEFIT-ALS to enable increased enrollment to approximately 680
patients and to update the statistical methods section, in both cases with the
objective to maintain the originally intended statistical power of the trial.
To date, over 500 patients have been enrolled in BENEFIT-ALS. Enrollment is
expected to continue as the new protocol amendment becomes effective at
participating investigative centers. The company now expects to complete
patient enrollment in BENEFIT-ALS during the second half of 2013, with results
to be available in early 2014. These changes to BENEFIT-ALS are expected to
increase the direct clinical trial costs by approximately $5 million in 2013
and 2014.
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