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

Last updated: March 23, 2015
Sponsor: University of Rochester
Overall Status: Terminated

Phase

3

Condition

Dyskinesias

Parkinson's Disease

Treatment

N/A

Clinical Study ID

NCT00449865
U01NS43128 NET-PD
CRC
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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/orrigidity) within 5 years of diagnosis

  • Treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for atleast 90 days, but not more than 2 years.

Exclusion

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'sability 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

Total Participants: 1741
Study Start date:
March 01, 2007
Estimated Completion Date:
May 31, 2014

Study 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.

Connect with a study center

  • University Of Calgary Movement Disorders Program, Dept Of Clin Neurosciences Area 3 Neurology, 3350 Hospital DR NW Health Sciences Centre

    Calgary, Alberta T2N4NI
    Canada

    Site Not Available

  • University Of Alberta, 10230-111 Avenue Room 0601, Movement Disorders Clinic Glenrose Rehab Hospital

    Edmonton, Alberta T5G 0B7
    Canada

    Site Not Available

  • University Of Alabama, Birmingham, 350 Sparks Center, 1720 7th Avenue South

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Barrow Neurological Clinics At, St Joseph's Hospital & Medical Center, 500 West Thomas Road Suite 720,

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Parkinson's & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204,

    Fountain Valley, California 92708
    United States

    Site Not Available

  • University Of Southern California, Healthcare Consultation Building II, 1520 San Pablo Street Suite 3000

    Los Angeles, California 90033
    United States

    Site Not Available

  • University Of California San Francisco, Parkinson's Disease Clinic And Research Cen, 505 Parnassus Avenue M-798

    San Francisco, California 94143-0114
    United States

    Site Not Available

  • The Parkinson's Institute, 675 Almanor Avenue

    Sunnyvale, California 94085
    United States

    Site Not Available

  • University Of Colorado Health Sciences Ctr, 4200 East 9th Avenue Campus Box C238, Department Of Clinical Pharmacy

    Denver, Colorado 80262
    United States

    Site Not Available

  • Neurodegenerative Disorders, 60 Temple Street Suite 8b

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • University Of Florida, Mcknight Brain Institute, 100 South Newell Drive Room L3-100

    Gainesville, Florida 32610
    United States

    Site Not Available

  • VA Medical Center, 1601 Southwest Archer Road, Neurology Service (151)

    Gainesville, Florida 32608
    United States

    Site Not Available

  • University Of Florida Jacksonville, 580 West 8th Street, Tower 1 8th Floor,

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University Of Miami, 1501 North West 9th Avenue Second Floor, Department Of Neurology D4-5

    Miami, Florida 33136
    United States

    Site Not Available

  • University Of South Florida, Movement Disorders Center, 5 Tampa General Circle Suite 410

    Tampa, Florida 33606
    United States

    Site Not Available

  • Emory University, Wesley Woods Health Center, 1841 Clifton Road NE Room 328

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Medical College Of Georgia, Movement Disorders Clinic, 1429 Harper Street HF 1121

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Pacific Health Research Institute, 405 North Kuakini Street, Suite 1011,

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Northwestern University, 710 North Lake Shore Drive

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Rush University Medical Center, Department Of Neurological Sciences, 1725 West Harrison Suite 755,

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Evanston Northwestern Healthcare, Department Of Neurology, 2100 Pfingsten Road Suite B110

    Glenview, Illinois 60026
    United States

    Site Not Available

  • Southern Illinois University School Of Medicine, PO Box 19645

    Springfield, Illinois 62794-9645
    United States

    Site Not Available

  • Indiana University School Of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University Of Kansas Medical Center, 3599 Rainbow Blvd, Department Of Neurology Mail Stop # 2012

    Kansas City, Kansas 66160-7314
    United States

    Site Not Available

  • University Of Kentucky Clinical Research, C201 Kentucky Clinic, 740 South Limestone Street

    Lexington, Kentucky 40536-0284
    United States

    Site Not Available

  • Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept. Of Neurology 7th Floor

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • LSU Health Science Center Shreveport, 1501 Kings Highway, Room 3-436

    Shreveport, Louisiana 71130
    United States

    Site Not Available

  • Johns Hopkins University, 601 North Caroline Street, Suite 5064

    Baltimore, Maryland 21287-0875
    United States

    Site Not Available

  • University Of Maryland School Of Medicine, Department Of Neurology, 22 South Greene Street N4W46

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center, 330 Brookline Avenue Shapiro 809D

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Brigham & Women's Hospital, Neurology Department ASB2, 75 Francis Street

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University Of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine,

    Ann Arbor, Michigan 48109-0028
    United States

    Site Not Available

  • Michigan State University, Department Of Neurology A217 Clinical Center, 138 Service Road

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Struthers Parkinson's Center, 6701 Country Club Drive,

    Golden Valley, Minnesota 55427
    United States

    Site Not Available

  • Washington University School Of Medicine, 660 South Euclid Avenue, Campus 8111,

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center, One Medical Center Drive, 2 Buck Road

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • UMDNJ Robert Wood Johnson Medical School, Dept Of Neurology Suite 6100, 125 Paterson Street

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • SUNY Downstate Medical Center, 450 Clarkson Avenue, Department Of Neurology Box 1213

    Brooklyn, New York 11203-2098
    United States

    Site Not Available

  • Northshore-LIJ Health System, The Feinstein Institute FPR Medical Research, 350 Community Drive Room,

    Manhasset, New York 11030
    United States

    Site Not Available

  • Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213,

    Durham, North Carolina 27705
    United States

    Site Not Available

  • OHSU Oregon Health &Science University, Department Of Neurology, 3181 South West Sam Jackson Park Road

    Portland, Oregon 97239
    United States

    Site Not Available

  • Thomas Jefferson University, 1015 Chestnut Street Suite 520

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pennsylvania; Pennsylvania Hospital, Penn Neurological Institute, 330 South Ninth Street

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Thomas Jefferson University/Lankenau Hospital, Lankenau Medical Building Suite 161 East, 100 Lancaster Avenue

    Wynnewood, Pennsylvania 19096
    United States

    Site Not Available

  • Medical University Of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308

    Charleston, South Carolina 29401
    United States

    Site Not Available

  • Vanderbilt University Medical Center, 2311 Pierce Avenue, Room 2217,

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • University Of Texas Southwestern Med Ctr. At Dallas, 5323 Harry Hines Boulevard H1-108

    Dallas, Texas 75390-9016
    United States

    Site Not Available

  • Baylor College Of Medicine, 6550 Fannin Suite 1801

    Houston, Texas 77030
    United States

    Site Not Available

  • University Of Vermont, Department Of Neurology , Given Building C-219, 89 Beaumont Avenue

    Burlington, Vermont 05405
    United States

    Site Not Available

  • University Of Virginia Neurology Fontaine, Department Of Neurology, 500 Ray C Hunt Drive

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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