Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL201)
This is a 2-part study of KNS-760704 in patients with ALS.
- Part 1 is a randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, and clinical effects of oral administration of 3 dosage levels of KNS 760704 vs. placebo for 12 weeks.
- Part 2 is a randomized, double-blind, 2-arm, parallel group, extension study evaluating the safety, tolerability, and clinical effects of oral administration of 2 dosage levels of KNS-760704 for up to 76 weeks.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A 2-Part, Randomized, Double-Blind, Safety and Tolerability Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS)|
- Number of subjects experiencing unacceptable safety or tolerability events after oral administration of KNS-760704 compared to placebo for 12 weeks in subjects with ALS (Part 1) [ Time Frame: 12 weeks ]
- Number of subjects experiencing unacceptable safety or tolerability events after oral administration of KNS-760704 compared to placebo for up to 76 weeks in subjects with ALS (Part 2) [ Time Frame: 76 weeks ]
- Change from Baseline in ALSFRS-R [ Time Frame: 12 weeks (part 1) and 28 weeks (part 2) ]
- Change from baseline to Week 12 in upright and supine vital capacity [ Time Frame: 12 weeks ]
- Changes in cystatin C and neurofilament H [ Time Frame: 12 weeks ]
|Study Start Date:||March 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
|Placebo Comparator: matched placebo||
Placebo oral tablet (2 tabs twice daily) for 12 weeks
|Experimental: low-dose KNS-760704||
Oral tablet 2 x 12.5 mg twice daily for 12 weeks
|Experimental: mid-dose KNS-760704||
Oral tablet 2 x 37.5 mg twice daily for 12 weeks
|Experimental: high-dose KNS-760704||
Oral tablet 2 x 75 mg twice daily for 12 weeks
This is a double-blind, randomized, placebo-controlled study evaluating the safety and efficacy of KNS-760704 compared to placebo. The study will be conducted in 2 parts.
In Part 1, approximately 80 eligible patients will be randomized to 1 of 4 treatment groups for 12 weeks of treatment: placebo; low-dose; mid-dose; or high-dose KNS-760704. Participants meeting eligibility requirements will be enrolled at approximately 20 centers in the U.S. In addition to the visit to determine eligibility and the first visit to take study drug, participants will be required to make 5 additional research clinic visits in Part 1.
Participants who complete all 12 weeks of Part 1 will be eligible for randomization to Part 2. The duration of Part 2 of the study is 76 weeks. Subjects will receive 1 of 2 active treatment groups for 72 weeks (low-dose or high-dose KNS-760704) and placebo for the remaining 4-week period in Part 2. Participants will not be told when the 4 weeks of placebo treatment will be given. During Part 2, participants will be required to make 12 research clinic visits, including the baseline visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647296
Show 21 Study Locations
|Study Director:||Evan Ingersoll, Ph.D.||Knopp Neurosciences Inc.|