Wise Young
08-06-2001, 01:51 AM
http://clinicaltrials.gov/ct/gui/c/a1b/show/NCT00005766?order=27&JServSession Idzone_ct=zhn5b9gan1 (http://clinicaltrials.gov/ct/gui/c/a1b/show/NCT00005766?order=27&JServSessionIdzone_ct=zhn5b9gan1)
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
This study is currently recruiting patients.
Sponsored by
National Center for Research Resources (NCRR)
Purpose
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 Huntington's 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 (8OH2'dG levels in urine), and the safety and tolerability of creatine.
Condition Treatment or Intervention Phase Amyotrophic Lateral Sclerosis
Drug:Creatinine
Phase II
MEDLINEplusrelated topics:AmyotrophicLateralSclerosis
Study Type:Interventional
Study Design:Treatment,Randomized,Double-Blind Method,Placebo Control,Safety/Efficacy Study
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both
Participants: Patients
Criteria
Inclusion Criteria:
* ALS
* FVC >=50%
* Abnormality in upper and/or lower extremity motor function * Not pregnant
* Disease duration <5 years
Location and Contact Information
Rup Tandan, MD, FRCP 1-802-656-8880
Vermont
University of Vermont,Burlington, Vermont, 05401, United States;Recruiting
Rup Tandan, M.D., FRCP 802-656-8880
More Information
Study ID Numbers NCRR-M01RR00109-0750; M01RR00109 NLM Identifier NCT00005766
Record last reviewed May 2000
[This message was edited by Wise Young on August 06, 2001 at 12:31 PM.]
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
This study is currently recruiting patients.
Sponsored by
National Center for Research Resources (NCRR)
Purpose
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 Huntington's 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 (8OH2'dG levels in urine), and the safety and tolerability of creatine.
Condition Treatment or Intervention Phase Amyotrophic Lateral Sclerosis
Drug:Creatinine
Phase II
MEDLINEplusrelated topics:AmyotrophicLateralSclerosis
Study Type:Interventional
Study Design:Treatment,Randomized,Double-Blind Method,Placebo Control,Safety/Efficacy Study
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both
Participants: Patients
Criteria
Inclusion Criteria:
* ALS
* FVC >=50%
* Abnormality in upper and/or lower extremity motor function * Not pregnant
* Disease duration <5 years
Location and Contact Information
Rup Tandan, MD, FRCP 1-802-656-8880
Vermont
University of Vermont,Burlington, Vermont, 05401, United States;Recruiting
Rup Tandan, M.D., FRCP 802-656-8880
More Information
Study ID Numbers NCRR-M01RR00109-0750; M01RR00109 NLM Identifier NCT00005766
Record last reviewed May 2000
[This message was edited by Wise Young on August 06, 2001 at 12:31 PM.]