|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00449865 |
|
Date of registration:
|
20/03/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
NET-PD LS-1 Creatine in Parkinson's Disease
|
|
Scientific title:
|
A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1) |
|
Date of first enrolment:
|
March 2007 |
|
Target sample size:
|
1741 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT00449865 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Canada
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Karl Kieburtz, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Coordination Center |
|
|
Name:
|
Barbara Tilley, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Statistics Center |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Willing and able to give informed consent and willing to commit to long-term follow-up
- PD (asymmetric features including slowness (bradykinesia) plus resting tremor and/or
rigidity) within 5 years of diagnosis
- Treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for at
least 90 days, but not more than 2 years.
Exclusion Criteria:
- Use of creatine 14 days prior to baseline or during the study
- History of known hypersensitivity or intolerability to creatine
- Any unstable or clinically significant condition that would impair the subject's
ability to comply with long term study follow-up
- Other know or suspected causes of parkinsonism (e.g. metabolic, drug induced, etc.),
or any significant features suggestive of a diagnosis of atypical parkinsonism.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Parkinson's Disease
|
|
Intervention(s)
|
|
Drug: creatine
|
|
Other: placebo
|
|
Primary Outcome(s)
|
|
The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.
[Time Frame: Change from baseline to 5 YEARS]
|
|
Secondary ID(s)
|
|
CRC
|
|
U01NS43128 NET-PD
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|