Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449865
Status:
TERMINATED
Last Update Posted:
2015-04-02
First Post:
2007-03-20
Brief Title:
NET-PD LS-1 Creatine in Parkinsons Disease
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A Multicenter Double-Blind Parallel Group Placebo Controlled Study of Creatine in Subjects With Treated Parkinsons Disease PD Long Term Study LS-1
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility
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 trial is to determine if the nutritional supplement creatine slows the progression of Parkinsons disease over time
Detailed Description:
Parkinsons disease PD affects nearly a million Americans a number that will increase over the coming decades as the population ages Symptoms of PD may include tremor rigidity or stiffness of the limbs and trunk slowness of movement and impaired balance and coordination These problems occur because as PD worsens some of the brain cells that control body movement die
This study will determine if creatine--an investigational compound--is able to slow the progression of PD Creatine a widely used dietary supplement is thought to improve exercise performance In animal models and human studies creatine has been shown to be well tolerated and may have some ability to protect brain cells
In the NET-PD LS-1 study 1720 participants will be randomly assigned to receive either creatine or a placebo inactive substance Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls
This study will determine if creatine--an investigational compound--is able to slow the progression of PD Creatine a widely used dietary supplement is thought to improve exercise performance In animal models and human studies creatine has been shown to be well tolerated and may have some ability to protect brain cells
In the NET-PD LS-1 study 1720 participants will be randomly assigned to receive either creatine or a placebo inactive substance Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRC | None | None | None |