NET-PD LS-1 Creatine in Parkinson's Disease
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Purpose
The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: creatine Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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) |
- using a global statistical test this study will compare disease progression at 5 years between the creatine and placebo groups. [ Time Frame: MINIMUM OF 5 YEARS TO A MAXIMUM OF 7 YEARS ] [ Designated as safety issue: Yes ]
- comparison of creatine and placebo groups on efficacy, safety and tolerability between baseline and 5 years of follow-up. [ Time Frame: MINIMUM OF 5 YEARS TO A MAXIMUM OF 7 YEARS ] [ Designated as safety issue: Yes ]
| Enrollment: | 1741 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Other: placebo
an inactive substance
|
|
Active Comparator: 2
creatine
|
Drug: creatine
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. The study is comparing creatine 5 grams twice daily with placebo. |
Detailed Description:
Parkinson's 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, 1,720 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Show 50 Study Locations| Principal Investigator: | Karl Kieburtz, MD | Coordination Center |
| Principal Investigator: | Barbara Tilley, PhD | Statistics Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Karl Kieburtz, Principal Investigator, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00449865 History of Changes |
| Other Study ID Numbers: | U01NS43128 NET-PD, CRC |
| Study First Received: | March 20, 2007 |
| Last Updated: | September 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Rochester:
|
Parkinson's disease creatine NET-PD neuroprotection PD |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 23, 2013