Clinical trial NCT00449865: NET-PD LS-1 Creatine in Parkinson's Disease
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
creatine
NET-PD
neuroprotection
PD
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2007-03-21
Enrollment: 1741
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

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