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

A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1)

Patrocinadores

Patrocinador principal: University of Rochester

Colaborador: National Institute of Neurological Disorders and Stroke (NINDS)

Fuente University of Rochester
Resumen breve

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

Descripción detallada

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.

Estado general Terminated
Fecha de inicio March 2007
Fecha de Terminación May 2014
Fecha de finalización primaria September 2013
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
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. Change from baseline to 5 YEARS
Inscripción 1741
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: creatine

Descripción: 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.

Etiqueta de grupo de brazo: creatine

Tipo de intervención: Other

Nombre de intervención: placebo

Descripción: an inactive substance

Etiqueta de grupo de brazo: Placebo

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: N/A

Edad máxima: N/A

Voluntarios Saludables: No

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

Canada

United States

Fecha de verificación

March 2015

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: University of Rochester

Nombre completo del investigador: Karl Kieburtz

Título del investigador: Principal Investigator

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Placebo

Tipo: Placebo Comparator

Etiqueta: creatine

Tipo: Active Comparator

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov