Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1741 participants
INTERVENTIONAL
2007-03-31
2014-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
placebo
an inactive substance
creatine
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.
Interventions
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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.
placebo
an inactive substance
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Rochester
OTHER
Responsible Party
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Karl Kieburtz
Principal Investigator
Principal Investigators
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Karl Kieburtz, MD
Role: PRINCIPAL_INVESTIGATOR
Coordination Center
Barbara Tilley, PhD
Role: PRINCIPAL_INVESTIGATOR
Statistics Center
Locations
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University Of Alabama, Birmingham, 350 Sparks Center, 1720 7th Avenue South
Birmingham, Alabama, United States
Barrow Neurological Clinics At, St Joseph's Hospital & Medical Center, 500 West Thomas Road Suite 720,
Phoenix, Arizona, United States
Parkinson's & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204,
Fountain Valley, California, United States
University Of Southern California, Healthcare Consultation Building II, 1520 San Pablo Street Suite 3000
Los Angeles, California, United States
University Of California San Francisco, Parkinson's Disease Clinic And Research Cen, 505 Parnassus Avenue M-798
San Francisco, California, United States
The Parkinson's Institute, 675 Almanor Avenue
Sunnyvale, California, United States
University Of Colorado Health Sciences Ctr, 4200 East 9th Avenue Campus Box C238, Department Of Clinical Pharmacy
Denver, Colorado, United States
Neurodegenerative Disorders, 60 Temple Street Suite 8b
New Haven, Connecticut, United States
VA Medical Center, 1601 Southwest Archer Road, Neurology Service (151)
Gainesville, Florida, United States
University Of Florida, Mcknight Brain Institute, 100 South Newell Drive Room L3-100
Gainesville, Florida, United States
University Of Florida Jacksonville, 580 West 8th Street, Tower 1 8th Floor,
Jacksonville, Florida, United States
University Of Miami, 1501 North West 9th Avenue Second Floor, Department Of Neurology D4-5
Miami, Florida, United States
University Of South Florida, Movement Disorders Center, 5 Tampa General Circle Suite 410
Tampa, Florida, United States
Emory University, Wesley Woods Health Center, 1841 Clifton Road NE Room 328
Atlanta, Georgia, United States
Medical College Of Georgia, Movement Disorders Clinic, 1429 Harper Street HF 1121
Augusta, Georgia, United States
Pacific Health Research Institute, 405 North Kuakini Street, Suite 1011,
Honolulu, Hawaii, United States
Northwestern University, 710 North Lake Shore Drive
Chicago, Illinois, United States
Rush University Medical Center, Department Of Neurological Sciences, 1725 West Harrison Suite 755,
Chicago, Illinois, United States
Evanston Northwestern Healthcare, Department Of Neurology, 2100 Pfingsten Road Suite B110
Glenview, Illinois, United States
Southern Illinois University School Of Medicine, PO Box 19645
Springfield, Illinois, United States
Indiana University School Of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
Indianapolis, Indiana, United States
University Of Kansas Medical Center, 3599 Rainbow Blvd, Department Of Neurology Mail Stop # 2012
Kansas City, Kansas, United States
University Of Kentucky Clinical Research, C201 Kentucky Clinic, 740 South Limestone Street
Lexington, Kentucky, United States
Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept. Of Neurology 7th Floor
New Orleans, Louisiana, United States
LSU Health Science Center Shreveport, 1501 Kings Highway, Room 3-436
Shreveport, Louisiana, United States
University Of Maryland School Of Medicine, Department Of Neurology, 22 South Greene Street N4W46
Baltimore, Maryland, United States
Johns Hopkins University, 601 North Caroline Street, Suite 5064
Baltimore, Maryland, United States
Brigham & Women's Hospital, Neurology Department ASB2, 75 Francis Street
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, 330 Brookline Avenue Shapiro 809D
Boston, Massachusetts, United States
University Of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine,
Ann Arbor, Michigan, United States
Michigan State University, Department Of Neurology A217 Clinical Center, 138 Service Road
East Lansing, Michigan, United States
Struthers Parkinson's Center, 6701 Country Club Drive,
Golden Valley, Minnesota, United States
Washington University School Of Medicine, 660 South Euclid Avenue, Campus 8111,
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center, One Medical Center Drive, 2 Buck Road
Lebanon, New Hampshire, United States
UMDNJ Robert Wood Johnson Medical School, Dept Of Neurology Suite 6100, 125 Paterson Street
New Brunswick, New Jersey, United States
SUNY Downstate Medical Center, 450 Clarkson Avenue, Department Of Neurology Box 1213
Brooklyn, New York, United States
Northshore-LIJ Health System, The Feinstein Institute FPR Medical Research, 350 Community Drive Room,
Manhasset, New York, United States
Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213,
Durham, North Carolina, United States
OHSU Oregon Health &Science University, Department Of Neurology, 3181 South West Sam Jackson Park Road
Portland, Oregon, United States
Thomas Jefferson University, 1015 Chestnut Street Suite 520
Philadelphia, Pennsylvania, United States
University of Pennsylvania; Pennsylvania Hospital, Penn Neurological Institute, 330 South Ninth Street
Philadelphia, Pennsylvania, United States
Thomas Jefferson University/Lankenau Hospital, Lankenau Medical Building Suite 161 East, 100 Lancaster Avenue
Wynnewood, Pennsylvania, United States
Medical University Of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308
Charleston, South Carolina, United States
Vanderbilt University Medical Center, 2311 Pierce Avenue, Room 2217,
Nashville, Tennessee, United States
University Of Texas Southwestern Med Ctr. At Dallas, 5323 Harry Hines Boulevard H1-108
Dallas, Texas, United States
Baylor College Of Medicine, 6550 Fannin Suite 1801
Houston, Texas, United States
University Of Vermont, Department Of Neurology , Given Building C-219, 89 Beaumont Avenue
Burlington, Vermont, United States
University Of Virginia Neurology Fontaine, Department Of Neurology, 500 Ray C Hunt Drive
Charlottesville, Virginia, United States
University Of Calgary Movement Disorders Program, Dept Of Clin Neurosciences Area 3 Neurology, 3350 Hospital DR NW Health Sciences Centre
Calgary, Alberta, Canada
University Of Alberta, 10230-111 Avenue Room 0601, Movement Disorders Clinic Glenrose Rehab Hospital
Edmonton, Alberta, Canada
Countries
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References
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Leehey M, Luo S, Sharma S, Wills AA, Bainbridge JL, Wong PS, Simon DK, Schneider J, Zhang Y, Perez A, Dhall R, Christine CW, Singer C, Cambi F, Boyd JT. Association of metabolic syndrome and change in Unified Parkinson's Disease Rating Scale scores. Neurology. 2017 Oct 24;89(17):1789-1794. doi: 10.1212/WNL.0000000000004572. Epub 2017 Sep 29.
Wills AM, Li R, Perez A, Ren X, Boyd J; NINDS NET-PD Investigators. Predictors of weight loss in early treated Parkinson's disease from the NET-PD LS-1 cohort. J Neurol. 2017 Aug;264(8):1746-1753. doi: 10.1007/s00415-017-8562-4. Epub 2017 Jul 15.
Augustine EF, Dorsey ER, Hauser RA, Elm JJ, Tilley BC, Kieburtz KK. Communicating with participants during the conduct of multi-center clinical trials. Clin Trials. 2016 Dec;13(6):592-596. doi: 10.1177/1740774516665596. Epub 2016 Aug 29.
Wills AM, Perez A, Wang J, Su X, Morgan J, Rajan SS, Leehey MA, Pontone GM, Chou KL, Umeh C, Mari Z, Boyd J; NINDS Exploratory Trials in Parkinson Disease (NET-PD) Investigators. Association Between Change in Body Mass Index, Unified Parkinson's Disease Rating Scale Scores, and Survival Among Persons With Parkinson Disease: Secondary Analysis of Longitudinal Data From NINDS Exploratory Trials in Parkinson Disease Long-term Study 1. JAMA Neurol. 2016 Mar;73(3):321-8. doi: 10.1001/jamaneurol.2015.4265.
Writing Group for the NINDS Exploratory Trials in Parkinson Disease (NET-PD) Investigators; Kieburtz K, Tilley BC, Elm JJ, Babcock D, Hauser R, Ross GW, Augustine AH, Augustine EU, Aminoff MJ, Bodis-Wollner IG, Boyd J, Cambi F, Chou K, Christine CW, Cines M, Dahodwala N, Derwent L, Dewey RB Jr, Hawthorne K, Houghton DJ, Kamp C, Leehey M, Lew MF, Liang GS, Luo ST, Mari Z, Morgan JC, Parashos S, Perez A, Petrovitch H, Rajan S, Reichwein S, Roth JT, Schneider JS, Shannon KM, Simon DK, Simuni T, Singer C, Sudarsky L, Tanner CM, Umeh CC, Williams K, Wills AM. Effect of creatine monohydrate on clinical progression in patients with Parkinson disease: a randomized clinical trial. JAMA. 2015 Feb 10;313(6):584-93. doi: 10.1001/jama.2015.120.
Other Identifiers
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CRC
Identifier Type: -
Identifier Source: secondary_id
U01NS43128 NET-PD
Identifier Type: -
Identifier Source: org_study_id
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