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

Primary Purpose

Parkinson's Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
creatine
placebo
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, creatine, NET-PD, neuroprotection, PD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Of Alabama, Birmingham, 350 Sparks Center, 1720 7th Avenue South
  • Barrow Neurological Clinics At, St Joseph's Hospital & Medical Center, 500 West Thomas Road Suite 720,
  • Parkinson's & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204,
  • University Of Southern California, Healthcare Consultation Building II, 1520 San Pablo Street Suite 3000
  • University Of California San Francisco, Parkinson's Disease Clinic And Research Cen, 505 Parnassus Avenue M-798
  • The Parkinson's Institute, 675 Almanor Avenue
  • University Of Colorado Health Sciences Ctr, 4200 East 9th Avenue Campus Box C238, Department Of Clinical Pharmacy
  • Neurodegenerative Disorders, 60 Temple Street Suite 8b
  • VA Medical Center, 1601 Southwest Archer Road, Neurology Service (151)
  • University Of Florida, Mcknight Brain Institute, 100 South Newell Drive Room L3-100
  • University Of Florida Jacksonville, 580 West 8th Street, Tower 1 8th Floor,
  • University Of Miami, 1501 North West 9th Avenue Second Floor, Department Of Neurology D4-5
  • University Of South Florida, Movement Disorders Center, 5 Tampa General Circle Suite 410
  • Emory University, Wesley Woods Health Center, 1841 Clifton Road NE Room 328
  • Medical College Of Georgia, Movement Disorders Clinic, 1429 Harper Street HF 1121
  • Pacific Health Research Institute, 405 North Kuakini Street, Suite 1011,
  • Northwestern University, 710 North Lake Shore Drive
  • Rush University Medical Center, Department Of Neurological Sciences, 1725 West Harrison Suite 755,
  • Evanston Northwestern Healthcare, Department Of Neurology, 2100 Pfingsten Road Suite B110
  • Southern Illinois University School Of Medicine, PO Box 19645
  • Indiana University School Of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
  • University Of Kansas Medical Center, 3599 Rainbow Blvd, Department Of Neurology Mail Stop # 2012
  • University Of Kentucky Clinical Research, C201 Kentucky Clinic, 740 South Limestone Street
  • Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept. Of Neurology 7th Floor
  • LSU Health Science Center Shreveport, 1501 Kings Highway, Room 3-436
  • University Of Maryland School Of Medicine, Department Of Neurology, 22 South Greene Street N4W46
  • Johns Hopkins University, 601 North Caroline Street, Suite 5064
  • Brigham & Women's Hospital, Neurology Department ASB2, 75 Francis Street
  • Beth Israel Deaconess Medical Center, 330 Brookline Avenue Shapiro 809D
  • University Of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine,
  • Michigan State University, Department Of Neurology A217 Clinical Center, 138 Service Road
  • Struthers Parkinson's Center, 6701 Country Club Drive,
  • Washington University School Of Medicine, 660 South Euclid Avenue, Campus 8111,
  • Dartmouth Hitchcock Medical Center, One Medical Center Drive, 2 Buck Road
  • UMDNJ Robert Wood Johnson Medical School, Dept Of Neurology Suite 6100, 125 Paterson Street
  • SUNY Downstate Medical Center, 450 Clarkson Avenue, Department Of Neurology Box 1213
  • Northshore-LIJ Health System, The Feinstein Institute FPR Medical Research, 350 Community Drive Room,
  • Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213,
  • OHSU Oregon Health &Science University, Department Of Neurology, 3181 South West Sam Jackson Park Road
  • Thomas Jefferson University, 1015 Chestnut Street Suite 520
  • University of Pennsylvania; Pennsylvania Hospital, Penn Neurological Institute, 330 South Ninth Street
  • Thomas Jefferson University/Lankenau Hospital, Lankenau Medical Building Suite 161 East, 100 Lancaster Avenue
  • Medical University Of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308
  • Vanderbilt University Medical Center, 2311 Pierce Avenue, Room 2217,
  • University Of Texas Southwestern Med Ctr. At Dallas, 5323 Harry Hines Boulevard H1-108
  • Baylor College Of Medicine, 6550 Fannin Suite 1801
  • University Of Vermont, Department Of Neurology , Given Building C-219, 89 Beaumont Avenue
  • University Of Virginia Neurology Fontaine, Department Of Neurology, 500 Ray C Hunt Drive
  • University Of Calgary Movement Disorders Program, Dept Of Clin Neurosciences Area 3 Neurology, 3350 Hospital DR NW Health Sciences Centre
  • University Of Alberta, 10230-111 Avenue Room 0601, Movement Disorders Clinic Glenrose Rehab Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

creatine

Arm Description

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Full Information

First Posted
March 20, 2007
Last Updated
March 23, 2015
Sponsor
University of Rochester
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00449865
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Futility
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, creatine, NET-PD, neuroprotection, PD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1741 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
creatine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
creatine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
an inactive substance
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
Change from baseline to 5 YEARS

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Kieburtz, MD
Organizational Affiliation
Coordination Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Tilley, PhD
Organizational Affiliation
Statistics Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Alabama, Birmingham, 350 Sparks Center, 1720 7th Avenue South
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Barrow Neurological Clinics At, St Joseph's Hospital & Medical Center, 500 West Thomas Road Suite 720,
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Parkinson's & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204,
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
University Of Southern California, Healthcare Consultation Building II, 1520 San Pablo Street Suite 3000
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University Of California San Francisco, Parkinson's Disease Clinic And Research Cen, 505 Parnassus Avenue M-798
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0114
Country
United States
Facility Name
The Parkinson's Institute, 675 Almanor Avenue
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
Facility Name
University Of Colorado Health Sciences Ctr, 4200 East 9th Avenue Campus Box C238, Department Of Clinical Pharmacy
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Neurodegenerative Disorders, 60 Temple Street Suite 8b
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
VA Medical Center, 1601 Southwest Archer Road, Neurology Service (151)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University Of Florida, Mcknight Brain Institute, 100 South Newell Drive Room L3-100
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University Of Florida Jacksonville, 580 West 8th Street, Tower 1 8th Floor,
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
University Of Miami, 1501 North West 9th Avenue Second Floor, Department Of Neurology D4-5
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University Of South Florida, Movement Disorders Center, 5 Tampa General Circle Suite 410
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University, Wesley Woods Health Center, 1841 Clifton Road NE Room 328
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Medical College Of Georgia, Movement Disorders Clinic, 1429 Harper Street HF 1121
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Pacific Health Research Institute, 405 North Kuakini Street, Suite 1011,
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Northwestern University, 710 North Lake Shore Drive
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center, Department Of Neurological Sciences, 1725 West Harrison Suite 755,
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Evanston Northwestern Healthcare, Department Of Neurology, 2100 Pfingsten Road Suite B110
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
Southern Illinois University School Of Medicine, PO Box 19645
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9645
Country
United States
Facility Name
Indiana University School Of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University Of Kansas Medical Center, 3599 Rainbow Blvd, Department Of Neurology Mail Stop # 2012
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7314
Country
United States
Facility Name
University Of Kentucky Clinical Research, C201 Kentucky Clinic, 740 South Limestone Street
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept. Of Neurology 7th Floor
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
LSU Health Science Center Shreveport, 1501 Kings Highway, Room 3-436
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
University Of Maryland School Of Medicine, Department Of Neurology, 22 South Greene Street N4W46
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University, 601 North Caroline Street, Suite 5064
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0875
Country
United States
Facility Name
Brigham & Women's Hospital, Neurology Department ASB2, 75 Francis Street
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center, 330 Brookline Avenue Shapiro 809D
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University Of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine,
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0028
Country
United States
Facility Name
Michigan State University, Department Of Neurology A217 Clinical Center, 138 Service Road
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Struthers Parkinson's Center, 6701 Country Club Drive,
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
Facility Name
Washington University School Of Medicine, 660 South Euclid Avenue, Campus 8111,
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center, One Medical Center Drive, 2 Buck Road
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
UMDNJ Robert Wood Johnson Medical School, Dept Of Neurology Suite 6100, 125 Paterson Street
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
SUNY Downstate Medical Center, 450 Clarkson Avenue, Department Of Neurology Box 1213
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203-2098
Country
United States
Facility Name
Northshore-LIJ Health System, The Feinstein Institute FPR Medical Research, 350 Community Drive Room,
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213,
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
OHSU Oregon Health &Science University, Department Of Neurology, 3181 South West Sam Jackson Park Road
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University, 1015 Chestnut Street Suite 520
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pennsylvania; Pennsylvania Hospital, Penn Neurological Institute, 330 South Ninth Street
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University/Lankenau Hospital, Lankenau Medical Building Suite 161 East, 100 Lancaster Avenue
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Medical University Of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Vanderbilt University Medical Center, 2311 Pierce Avenue, Room 2217,
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
University Of Texas Southwestern Med Ctr. At Dallas, 5323 Harry Hines Boulevard H1-108
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9016
Country
United States
Facility Name
Baylor College Of Medicine, 6550 Fannin Suite 1801
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Of Vermont, Department Of Neurology , Given Building C-219, 89 Beaumont Avenue
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
University Of Virginia Neurology Fontaine, Department Of Neurology, 500 Ray C Hunt Drive
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
University Of Calgary Movement Disorders Program, Dept Of Clin Neurosciences Area 3 Neurology, 3350 Hospital DR NW Health Sciences Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4NI
Country
Canada
Facility Name
University Of Alberta, 10230-111 Avenue Room 0601, Movement Disorders Clinic Glenrose Rehab Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28972194
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.
Results Reference
derived
PubMed Identifier
28712000
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.
Results Reference
derived
PubMed Identifier
27573636
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.
Results Reference
derived
PubMed Identifier
26751506
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.
Results Reference
derived
PubMed Identifier
25668262
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.
Results Reference
derived

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

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