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

This study has been terminated.
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Karl Kieburtz, University of Rochester Identifier:
First received: March 20, 2007
Last updated: March 23, 2015
Last verified: March 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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)

Resource links provided by NLM:

Further study details as provided by Karl Kieburtz, University of Rochester:

Primary Outcome Measures:
  • 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 ]
    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).

Enrollment: 1741
Study Start Date: March 2007
Study Completion Date: May 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: placebo
an inactive substance
Active Comparator: 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00449865

  Show 50 Study Locations
Sponsors and Collaborators
University of Rochester
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Karl Kieburtz, MD Coordination Center
Principal Investigator: Barbara Tilley, PhD Statistics Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Karl Kieburtz, Principal Investigator, University of Rochester Identifier: NCT00449865     History of Changes
Other Study ID Numbers: U01NS43128 NET-PD
Study First Received: March 20, 2007
Results First Received: February 19, 2015
Last Updated: March 23, 2015

Keywords provided by Karl Kieburtz, University of Rochester:
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases processed this record on May 25, 2017