Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00449865
Recruitment Status : Terminated (Futility)
First Posted : March 21, 2007
Results First Posted : April 2, 2015
Last Update Posted : April 2, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Karl Kieburtz, University of Rochester

Tracking Information
First Submitted Date  ICMJE March 20, 2007
First Posted Date  ICMJE March 21, 2007
Results First Submitted Date  ICMJE February 19, 2015
Results First Posted Date  ICMJE April 2, 2015
Last Update Posted Date April 2, 2015
Study Start Date  ICMJE March 2007
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2007)
using a global statistical test this study will compare disease progression at 5 years between the creatine and placebo groups.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2007)
comparison of creatine and placebo groups on efficacy, safety and tolerability between baseline and 5 years of follow-up.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NET-PD LS-1 Creatine in Parkinson's Disease
Official Title  ICMJE A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • 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.

  • Other: placebo
    an inactive substance
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Other: placebo
  • Active Comparator: creatine
    Intervention: Drug: creatine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 12, 2010)
1741
Original Enrollment  ICMJE
 (submitted: March 20, 2007)
1720
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00449865
Other Study ID Numbers  ICMJE U01NS43128 NET-PD
CRC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karl Kieburtz, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Karl Kieburtz, MD Coordination Center
Principal Investigator: Barbara Tilley, PhD Statistics Center
PRS Account University of Rochester
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP