Status:
COMPLETED
Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Cytokinetics
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 o...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Able to comprehend and willing to sign an Informed Consent Form (ICF)
- Males or females 18 years of age or older
- A diagnosis of familial or sporadic ALS (defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria)
- Maximum voluntary grip strength in at least one hand between 10 \& 40 pounds (females) and 10 \& 60 pounds (males)
- Able to swallow tablets with water
- Currently taking and tolerating a stable dose of 50 mg BID riluzole
- Willing and able to reduce daily dose of riluzole to 50mg QD for 5 weeks
- Not currently taking or willing and able to remain off theophylline-containing medications during study participation
- Patient has a caregiver who is capable of observing and reporting patient status
- Upright Slow Vital Capacity (SVC) \>50% of predicted for age, height, and sex
- Able to perform pulmonary function tests
Exclusion
- Life expectancy \<3 months
- Receipt of investigational study drug within 30 days or 5 half-lives of the prior agent, whichever is greater, prior to dosing
- Any prior treatment with CK-2017357
- Any use of non-invasive positive pressure ventilation (NIPPV), such as Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP)
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01486849
Start Date
November 1 2011
End Date
March 1 2012
Last Update
May 3 2019
Active Locations (11)
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1
University of California at San Francisco, Fresno Campus, Central California Neurological Institute
Fresno, California, United States, 93701
2
Coordinated Clinical Research
La Jolla, California, United States, 92037
3
University of California at Irvine, ALS and Neuromuscular Center
Orange, California, United States, 92868
4
Hospital for Special Care
New Britain, Connecticut, United States, 06053