Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
A Phase II, Multicenter, Double-Blind, Randomized, Placebo-Controlled Dose Titration Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)
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).
Patients will be randomized to one of two dosing groups, active CK-2017357 or placebo, in a
3:1 ratio. Prior to study drug dosing, patients will be required to decrease their riluzole
dose to 50 mg QD for 7 days; after this 7 day period patients will either receive placebo or
start the titration on active CK-2017357 while continuing to take riluzole at 50 mg QD.
Potential patients will be screened to assess their eligibility to enter the study within 21
days prior to Day -7, when they will begin taking riluzole at the decreased dose of 50 mg QD.
Patients will be randomized in a 3:1 ratio to CK-2017357 (Group 1) or placebo (Group 2). On
Day 1, patients will begin taking a total daily dose of 250 mg (125 mg BID) of CK-2017357 or
matching placebo tablets BID for 7 days. Then they will take a total daily dose of 375 mg
(125 mg morning [AM] and 250 mg evening [PM]) of CK-2017357 or matching placebo tablets BID
for 7 days, and finally, they will take a total daily dose of 500 mg (250 mg BID) of
CK-2017357 or matching placebo tablets BID for 7 days. A final dose of 250 mg of CK-2017357
or placebo will be taken in the morning on Day 22 at the study site.
Dose-escalation of CK-2017357 or placebo may be stopped, or the dose reduced to a lower
level, based on tolerability. All patients who return to a lower dose will stay on that dose
for the remainder of the study.
Patients will remain on the decreased dose of riluzole until the follow-up visit
approximately 7 days after Day 22.
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