A Study of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Purpose
The primary objective of this study is to demonstrate a pharmacodynamic effect of CK 2017357 on measures of skeletal muscle function or fatigability in patients with ALS.
Further study details as provided by Cytokinetics:
Primary Outcome Measures:
- The primary objective of this study is to demonstrate a pharmacodynamic effect of CK-2017357 on measures of skeletal muscle function or fatigability in patients with ALS. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
In this hypothesis-generating early Phase II study, multiple assessments of skeletal muscle function will be made without specifying a single primary endpoint, including:
1. ALS Functional Assessment
2. Maximum Grip Strength (bilateral)
3. Maximum Grip Strength Fatigability (bilateral)
4. Shoulder Extension Fatigue (bilateral)
5. Slow Vital Capacity
6. Maximal Voluntary Ventilation
7. Sniff Inspiratory Pressure
8. Maximum Voluntary Muscle Contraction of multiple bilateral muscle groups using Hand Held Dynamometry
9. Repeated Sub-Maximum Grip Strength Fatigability (bilateral)
Secondary Outcome Measures:
- To evaluate and characterize the relationship, if any, between the plasma concentration of CK-2017357 and its pharmacodynamic effects (PK/PD relationship) [ Time Frame: 2 day ] [ Designated as safety issue: No ]
- To evaluate the safety and tolerability of 2 doses of CK-2017357 given as single doses administered orally to patients with ALS [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- To evaluate the effect of CK-2017357 on patient and investigator determined global functional assessment [ Time Frame: 2 days ] [ Designated as safety issue: No ]
For further information about this study contact Katy Shaver, CCRP.
Also, please click here for more information.
April, 2010
