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

Parkinson's Disease Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00449865
• Other study ID #: U01NS43128 NET-PD
• Secondary ID: CRC
• Status: Terminated
• Phase: Phase 3
• First received: March 20, 2007
• Last updated: March 23, 2015
• Start date: March 2007
• Est. completion date: May 2014

Study information

• Verified date: March 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1741
• Est. completion date: May 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Other:
• placebo
an inactive substance

Locations

Country	Name	City	State
Canada	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
United States	University Of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine,	Ann Arbor	Michigan
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	Johns Hopkins University, 601 North Caroline Street, Suite 5064	Baltimore	Maryland
United States	University Of Maryland School Of Medicine, Department Of Neurology, 22 South Greene Street N4W46	Baltimore	Maryland
United States	University Of Alabama, Birmingham, 350 Sparks Center, 1720 7th Avenue South	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center, 330 Brookline Avenue Shapiro 809D	Boston	Massachusetts
United States	Brigham & Women's Hospital, Neurology Department ASB2, 75 Francis Street	Boston	Massachusetts
United States	SUNY Downstate Medical Center, 450 Clarkson Avenue, Department Of Neurology Box 1213	Brooklyn	New York
United States	University Of Vermont, Department Of Neurology , Given Building C-219, 89 Beaumont Avenue	Burlington	Vermont
United States	Medical University Of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308	Charleston	South Carolina
United States	University Of Virginia Neurology Fontaine, Department Of Neurology, 500 Ray C Hunt Drive	Charlottesville	Virginia
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	University Of Texas Southwestern Med Ctr. At Dallas, 5323 Harry Hines Boulevard H1-108	Dallas	Texas
United States	University Of Colorado Health Sciences Ctr, 4200 East 9th Avenue Campus Box C238, Department Of Clinical Pharmacy	Denver	Colorado
United States	Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213,	Durham	North Carolina
United States	Michigan State University, Department Of Neurology A217 Clinical Center, 138 Service Road	East Lansing	Michigan
United States	Parkinson's & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204,	Fountain Valley	California
United States	University Of Florida, Mcknight Brain Institute, 100 South Newell Drive Room L3-100	Gainesville	Florida
United States	VA Medical Center, 1601 Southwest Archer Road, Neurology Service (151)	Gainesville	Florida
United States	Evanston Northwestern Healthcare, Department Of Neurology, 2100 Pfingsten Road Suite B110	Glenview	Illinois
United States	Struthers Parkinson's Center, 6701 Country Club Drive,	Golden Valley	Minnesota
United States	Pacific Health Research Institute, 405 North Kuakini Street, Suite 1011,	Honolulu	Hawaii
United States	Baylor College Of Medicine, 6550 Fannin Suite 1801	Houston	Texas
United States	Indiana University School Of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150	Indianapolis	Indiana
United States	University Of Florida Jacksonville, 580 West 8th Street, Tower 1 8th Floor,	Jacksonville	Florida
United States	University Of Kansas Medical Center, 3599 Rainbow Blvd, Department Of Neurology Mail Stop # 2012	Kansas City	Kansas
United States	Dartmouth Hitchcock Medical Center, One Medical Center Drive, 2 Buck Road	Lebanon	New Hampshire
United States	University Of Kentucky Clinical Research, C201 Kentucky Clinic, 740 South Limestone Street	Lexington	Kentucky
United States	University Of Southern California, Healthcare Consultation Building II, 1520 San Pablo Street Suite 3000	Los Angeles	California
United States	Northshore-LIJ Health System, The Feinstein Institute FPR Medical Research, 350 Community Drive Room,	Manhasset	New York
United States	University Of Miami, 1501 North West 9th Avenue Second Floor, Department Of Neurology D4-5	Miami	Florida
United States	Vanderbilt University Medical Center, 2311 Pierce Avenue, Room 2217,	Nashville	Tennessee
United States	UMDNJ Robert Wood Johnson Medical School, Dept Of Neurology Suite 6100, 125 Paterson Street	New Brunswick	New Jersey
United States	Neurodegenerative Disorders, 60 Temple Street Suite 8b	New Haven	Connecticut
United States	Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept. Of Neurology 7th Floor	New Orleans	Louisiana
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	Barrow Neurological Clinics At, St Joseph's Hospital & Medical Center, 500 West Thomas Road Suite 720,	Phoenix	Arizona
United States	OHSU Oregon Health &Science University, Department Of Neurology, 3181 South West Sam Jackson Park Road	Portland	Oregon
United States	University Of California San Francisco, Parkinson's Disease Clinic And Research Cen, 505 Parnassus Avenue M-798	San Francisco	California
United States	LSU Health Science Center Shreveport, 1501 Kings Highway, Room 3-436	Shreveport	Louisiana
United States	Southern Illinois University School Of Medicine, PO Box 19645	Springfield	Illinois
United States	Washington University School Of Medicine, 660 South Euclid Avenue, Campus 8111,	St Louis	Missouri
United States	The Parkinson's Institute, 675 Almanor Avenue	Sunnyvale	California
United States	University Of South Florida, Movement Disorders Center, 5 Tampa General Circle Suite 410	Tampa	Florida
United States	Thomas Jefferson University/Lankenau Hospital, Lankenau Medical Building Suite 161 East, 100 Lancaster Avenue	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline to 5 YEARS	Yes