Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005766
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-06-01
Brief Title:
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determine whether creatine slows disease progression in subjects with amyotrophic lateral sclerosis ALS ALS is a progressive uniformly lethal neurodegenerative disorder for which there is no known cure Recent genetic and biochemical studies implicate free radical toxicity glutamate excitotoxicity and mitochondrial dysfunction as possible causes of familial ALS FALS and sporadic ALS SALS It has been hypothesized that in ALS there may be involvement of oxidative free radical damage and impaired mitochondrial energy metabolism that could in turn lead to excitotoxic cell death Creatine an agent that improves mitochondrial function has been shown to be neuroprotective in animal models of ALS and Huntingtons disease
This study is a double-blind randomized placebo-controlled trial of the safety and efficacy of creatine in patients with ALS enrolled at sites distributed throughout the United States including Northeast ALS NEALS sites The study will provide preliminary data on the safety and efficacy of creatine in ALS If creatine slows disease progression in ALS and is well tolerated a phase 3 study with survival as the primary outcome measure will be initiated
114 eligible subjects will be randomized to receive treatment for 6 months of 1 active creatine or 2 placebo After randomization subjects will be followed prospectively for 6 months The primary outcome measure for the study is the change in upper extremity motor function after 6 months of experimental therapy as tested with the Tufts Quantitative Neuromuscular Exam Strength in eight arm muscles will be measured bilateral shoulder and elbow flexion and extension Secondary outcome measures include grip strength motor unit number estimates MUNE the ALS functional rating score-revised ALSFRS-R and rate of change of a well established biochemical marker of oxidative damage to DNA 8OH2dG levels in urine and the safety and tolerability of creatine
This study is a double-blind randomized placebo-controlled trial of the safety and efficacy of creatine in patients with ALS enrolled at sites distributed throughout the United States including Northeast ALS NEALS sites The study will provide preliminary data on the safety and efficacy of creatine in ALS If creatine slows disease progression in ALS and is well tolerated a phase 3 study with survival as the primary outcome measure will be initiated
114 eligible subjects will be randomized to receive treatment for 6 months of 1 active creatine or 2 placebo After randomization subjects will be followed prospectively for 6 months The primary outcome measure for the study is the change in upper extremity motor function after 6 months of experimental therapy as tested with the Tufts Quantitative Neuromuscular Exam Strength in eight arm muscles will be measured bilateral shoulder and elbow flexion and extension Secondary outcome measures include grip strength motor unit number estimates MUNE the ALS functional rating score-revised ALSFRS-R and rate of change of a well established biochemical marker of oxidative damage to DNA 8OH2dG levels in urine and the safety and tolerability of creatine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000109 | NIH | None | httpsreporternihgovquickSearchM01RR000109 |