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

March 23, 2015 updated by: Karl Kieburtz, University of Rochester

A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1741

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4NI
        • University Of Calgary Movement Disorders Program, Dept Of Clin Neurosciences Area 3 Neurology, 3350 Hospital DR NW Health Sciences Centre
      • Edmonton, Alberta, Canada, T5G 0B7
        • University Of Alberta, 10230-111 Avenue Room 0601, Movement Disorders Clinic Glenrose Rehab Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Clinics At, St Joseph's Hospital & Medical Center, 500 West Thomas Road Suite 720,
    • California
      • Fountain Valley, California, United States, 92708
        • Parkinson's & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204,
      • Los Angeles, California, United States, 90033
        • University Of Southern California, Healthcare Consultation Building II, 1520 San Pablo Street Suite 3000
      • San Francisco, California, United States, 94143-0114
        • University Of California San Francisco, Parkinson's Disease Clinic And Research Cen, 505 Parnassus Avenue M-798
      • Sunnyvale, California, United States, 94085
        • The Parkinson's Institute, 675 ALMANOR AVENUE
    • Colorado
      • Denver, Colorado, United States, 80262
        • University Of Colorado Health Sciences Ctr, 4200 East 9th Avenue Campus Box C238, Department Of Clinical Pharmacy
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Neurodegenerative Disorders, 60 Temple Street Suite 8b
    • Florida
      • Gainesville, Florida, United States, 32608
        • VA Medical Center, 1601 Southwest Archer Road, Neurology Service (151)
      • Gainesville, Florida, United States, 32610
        • University Of Florida, Mcknight Brain Institute, 100 South Newell Drive Room L3-100
      • Jacksonville, Florida, United States, 32209
        • University Of Florida Jacksonville, 580 West 8th Street, Tower 1 8th Floor,
      • Miami, Florida, United States, 33136
        • University of Miami, 1501 North West 9Th Avenue Second Floor, Department of Neurology D4-5
      • Tampa, Florida, United States, 33606
        • University Of South Florida, Movement Disorders Center, 5 Tampa General Circle Suite 410
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University, Wesley Woods Health Center, 1841 Clifton Road NE Room 328
      • Augusta, Georgia, United States, 30912
        • Medical College Of Georgia, Movement Disorders Clinic, 1429 Harper Street HF 1121
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Pacific Health Research Institute, 405 North Kuakini Street, Suite 1011,
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University, 710 North Lake Shore Drive
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center, Department Of Neurological Sciences, 1725 West Harrison Suite 755,
      • Glenview, Illinois, United States, 60026
        • Evanston Northwestern Healthcare, Department Of Neurology, 2100 Pfingsten Road Suite B110
      • Springfield, Illinois, United States, 62794-9645
        • Southern Illinois University School Of Medicine, PO Box 19645
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
    • Kansas
      • Kansas City, Kansas, United States, 66160-7314
        • University Of Kansas Medical Center, 3599 Rainbow Blvd, Department Of Neurology Mail Stop # 2012
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0284
        • University Of Kentucky Clinical Research, C201 Kentucky Clinic, 740 South Limestone Street
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept. Of Neurology 7th Floor
      • Shreveport, Louisiana, United States, 71130
        • LSU Health Science Center Shreveport, 1501 Kings Highway, Room 3-436
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University Of Maryland School Of Medicine, Department Of Neurology, 22 South Greene Street N4W46
      • Baltimore, Maryland, United States, 21287-0875
        • Johns Hopkins University, 601 North Caroline Street, Suite 5064
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital, Neurology Department ASB2, 75 Francis Street
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center, 330 Brookline Avenue Shapiro 809D
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0028
        • University Of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine,
      • East Lansing, Michigan, United States, 48824
        • Michigan State University, Department Of Neurology A217 Clinical Center, 138 Service Road
    • Minnesota
      • Golden Valley, Minnesota, United States, 55427
        • Struthers Parkinson's Center, 6701 Country Club Drive,
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School Of Medicine, 660 South Euclid Avenue, Campus 8111,
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center, One Medical Center Drive, 2 Buck Road
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • UMDNJ Robert Wood Johnson Medical School, Dept Of Neurology Suite 6100, 125 Paterson Street
    • New York
      • Brooklyn, New York, United States, 11203-2098
        • SUNY Downstate Medical Center, 450 Clarkson Avenue, Department Of Neurology Box 1213
      • Manhasset, New York, United States, 11030
        • Northshore-LIJ Health System, The Feinstein Institute FPR Medical Research, 350 Community Drive Room,
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213,
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU Oregon Health &Science University, Department Of Neurology, 3181 South West Sam Jackson Park Road
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University, 1015 Chestnut Street Suite 520
      • Philadelphia, Pennsylvania, United States, 19107
        • University of Pennsylvania; Pennsylvania Hospital, Penn Neurological Institute, 330 South Ninth Street
      • Wynnewood, Pennsylvania, United States, 19096
        • Thomas Jefferson University/Lankenau Hospital, Lankenau Medical Building Suite 161 East, 100 Lancaster Avenue
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Medical University of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center, 2311 Pierce Avenue, Room 2217,
    • Texas
      • Dallas, Texas, United States, 75390-9016
        • University Of Texas Southwestern Med Ctr. At Dallas, 5323 Harry Hines Boulevard H1-108
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine, 6550 Fannin Suite 1801
    • Vermont
      • Burlington, Vermont, United States, 05405
        • University Of Vermont, Department Of Neurology , Given Building C-219, 89 Beaumont Avenue
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University Of Virginia Neurology Fontaine, Department Of Neurology, 500 Ray C Hunt Drive

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from baseline to 5 YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Karl Kieburtz, MD, Coordination Center
  • Principal Investigator: Barbara Tilley, PhD, Statistics Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (Estimate)

March 21, 2007

Study Record Updates

Last Update Posted (Estimate)

April 2, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01NS43128 NET-PD
  • CRC (NINDS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe