NET-PD LS-1 Creatine in Parkinson's Disease

Phase 3

Terminated

• Conditions: Parkinson's Disease
• Interventions: Other: placebo; Drug: creatine

• Registration Number: NCT00449865
• Lead Sponsor: University of Rochester

Brief Summary

The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-20
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-21
• Primary Completion: 2013-09
• Study Completion: 2014-05
• Results First Submitted: 2015-02-19
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-23
• Last Update Submitted: 2015-03-23
• Results First Posted: 2015-04-02
• Last Update Posted: 2015-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1741

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
creatine	creatine	-

Primary Outcome Measures

Name	Time	Method
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.	Change from baseline to 5 YEARS	All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).

Trial Locations

Locations (50)

University Of Alabama, Birmingham, 350 Sparks Center, 1720 7th Avenue South; 🇺🇸 Birmingham, Alabama, United States

Barrow Neurological Clinics At, St Joseph's Hospital & Medical Center, 500 West Thomas Road Suite 720,; 🇺🇸 Phoenix, Arizona, United States

Parkinson's & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204,; 🇺🇸 Fountain Valley, California, United States

University Of Southern California, Healthcare Consultation Building II, 1520 San Pablo Street Suite 3000; 🇺🇸 Los Angeles, California, United States

University Of California San Francisco, Parkinson's Disease Clinic And Research Cen, 505 Parnassus Avenue M-798; 🇺🇸 San Francisco, California, United States

The Parkinson's Institute, 675 Almanor Avenue; 🇺🇸 Sunnyvale, California, United States

University Of Colorado Health Sciences Ctr, 4200 East 9th Avenue Campus Box C238, Department Of Clinical Pharmacy; 🇺🇸 Denver, Colorado, United States

Neurodegenerative Disorders, 60 Temple Street Suite 8b; 🇺🇸 New Haven, Connecticut, United States

VA Medical Center, 1601 Southwest Archer Road, Neurology Service (151); 🇺🇸 Gainesville, Florida, United States

University Of Florida, Mcknight Brain Institute, 100 South Newell Drive Room L3-100; 🇺🇸 Gainesville, Florida, United States

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