Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005674
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-05-26
Brief Title:
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis ALS
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 purpose of this study is to evaluate the safety and effectiveness of creatine treatment in amyotrophic lateral sclerosis ALS There is currently no known effective treatment for ALS It is known that nerve cells die in the brains and spinal cords of patients with ALS but the cause of the cell death is unknown It has been shown that there is overactive nerve activity due to increased levels of a chemical called glutamate and that there is abnormal cellular metabolism along with increased production of substance called free radicals Improving cellular metabolism and readjusting the activity of glutamate in the brain may be beneficial to ALS patients
Creatine is a naturally occurring compound which improves energy metabolism in cells Creatine has been given to patients with energy metabolism defects in their muscles and to athletes Creatine improves survival in a mouse model of ALS Three human subjects with ALS have received creatine for up to six months without any side effects Overall creatine has been well tolerated and safe
Creatine is a naturally occurring compound which improves energy metabolism in cells Creatine has been given to patients with energy metabolism defects in their muscles and to athletes Creatine improves survival in a mouse model of ALS Three human subjects with ALS have received creatine for up to six months without any side effects Overall creatine has been well tolerated and safe
Detailed Description:
Half of the subjects in this study will be selected by chance to receive creatine treatment for 6 months and the other half to receive placebo Neither the subject nor the investigator will know which drug the subject is receiving although this information will be available in case of emergency It is anticipated that all subjects will have the choice to receive creatine after the 6 months study in an open-label study for an additional 12 months A total of 114 patients will participate at 15 centers Approximately 8 subjects will be enrolled at the Washington University
The effectiveness of creatine will be determined first by assessing any changes in strength in the arms and second by changes in grip strength functional activities electromyography changes or changes of the level of SOH 2dG in the urine
The effectiveness of creatine will be determined first by assessing any changes in strength in the arms and second by changes in grip strength functional activities electromyography changes or changes of the level of SOH 2dG in the urine
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 |
|---|---|---|---|
| M01RR000036 | NIH | None | httpsreporternihgovquickSearchM01RR000036 |