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

This study has been terminated.
(Futility)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karl Kieburtz, University of Rochester
ClinicalTrials.gov Identifier:
NCT00449865
First received: March 20, 2007
Last updated: November 3, 2013
Last verified: November 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University of Rochester:

Primary Outcome Measures:
  • using a global statistical test this study will compare disease progression at 5 years between the creatine and placebo groups. [ Time Frame: MINIMUM OF 5 YEARS TO A MAXIMUM OF 7 YEARS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • comparison of creatine and placebo groups on efficacy, safety and tolerability between baseline and 5 years of follow-up. [ Time Frame: MINIMUM OF 5 YEARS TO A MAXIMUM OF 7 YEARS ] [ Designated as safety issue: Yes ]

Enrollment: 1741
Study Start Date: March 2007
Estimated Study Completion Date: June 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Other: placebo
an inactive substance
Active Comparator: 2
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449865

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

Additional Information:
No publications provided

Responsible Party: Karl Kieburtz, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT00449865     History of Changes
Other Study ID Numbers: U01NS43128 NET-PD, CRC
Study First Received: March 20, 2007
Last Updated: November 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Parkinson's disease
creatine
NET-PD
neuroprotection
PD

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 14, 2014