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“I feel like there is hope, great hope, more hope now than ever before.” –Peggy Willocks, Diagnosed 14 years

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Recently Diagnosed with Parkinson's Disease?

If you have recently been diagnosed with Parkinson’s disease (PD) understanding the disease, and learning about the resources available to you, are good first steps.

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NET-PD LS-1 Creatine in Parkinson's Disease - Recruiting 1720 Participants!

Official Study Title: A Multicenter, Double-Blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. Parallel Group, Placebo  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. Controlled Study of Creatine in Subjects with Treated Parkinson's Disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD) Long term Study (LS-1)
Sponsor: National Institute of Neurological Disorders and Stroke  National Institute of Neurological Disorders and Stroke (NINDS)A branch of the National Institutes of Health whose research concentrates on the brain and conditions that result in brain function irregularities. The NINDS funds much of the research on Parkinson's disease. Internet address: http://www.ninds.nih.gov (NINDS)
Clinicaltrials.gov ID:
Study ID:

Summary

NET-PD is a large NIH-sponsored effort to find drugs that slow the progression of Parkinson's disease. Recruitment is currently underway for a study of the nutritional supplement creatine in more than 1700 participants.

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,  TremorShaking or rhythmic movement, especially in the hands but in other parts of the body. Often occurs when at rest, such as in the RESTING TREMOR. rigidity  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. 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 drug-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. Although basic forms of the supplement are generally available on retail shelves, the creatine used in this study is significantly different. It is a clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. form, called PD-02, and is provided to the study investigators by Avicena Group, Inc.

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.

Study Phase

Phase 3
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

  • More than six months
  • At least 9 follow-up clinic visits and at least 3 telephone calls within a minimum of 5 years

Eligibility

  • Gender(s) Accepted: Either

Inclusion Criteria

  • Willing and able to gives informed consent  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial. and willing to commit to long-term follow-up
  • PD (asymmetric features including slowness-- bradykinesia-- plus resting tremor  Resting TremorA tremor of a limb that increases when the limb is at rest. and/or rigidity) within 5 years of diagnosis
  • Treated/responsive to dopaminergic therapy  TherapyAnother word for “treatment”. (dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. agonists or levodopa)  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. for at least 90 days, but not more than 2 years

Exclusion Criteria

  • Use of creatine 14 days prior to baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. or during the study
  • History of known hypersensitivity or intolerability to creatine
  • Any unstable or clinically significant condition that would impair the participant's ability to comply with long term study follow-up
  • Other known or suspected causes of parkinsonism (e.g. metabolic, drug induced, etc.), or any significant features suggestive of a diagnosis of atypical parkinsonism.

Enrollment

Expected Enrollment: 1720 (US)
Date Enrollment Began: Mar 22 2007
Last Updated Date: Nov 01 2007
Trial Post Date: Nov 01 2007
Website: http://www.parkinsontrial.ninds.nih.gov/

Primary Contacts and Locations

New York

Local Contacts and Locations

Alberta

  • Lorelei Derwent — Study Coordinator
    University of Calgary Movement Disorders Program
    Phone: 403-220-8413
    Dept. of Clin. Neurosciences
    Area 3 Neurology,  NeurologyThe scientific study of the nervous system, especially in respect to its structure, functions, and abnormalities. 3350 Hospital DR NW Health Sciences Centre
    Calgary, AB
    Canada
  • Germaine Mcinnes — Study Coordinator
    University of Alberta
    Phone: 780-735-8853
    10230-111 Avenue Room 0601
    Movement Disorders Clinic Glenrose Rehab Hospital
    Edmonton, AB
    Canada

Alabama

  • Rebecca Mcmurray — Study Coordinator
    University of Alabama at Birmingham
    Phone: 205-996-4034
    350 Sparks Center
    1720 7th Avenue, South
    Birmingham, AL 35233
    USA

Arizona

  • Lynn L. Marlor — Study Coordinator
    Barrow Neurological Clinics at St. Joseph's Hospital & Medical Center
    Phone: 602-406-6259
    St. Joseph's Hospital & Medical Center
    500 West Thomas Road Suite 720
    Phoenix, AZ 85013
    USA

California

  • Katie Ersted — Study Coordinator
    The Parkinson's Institute
    Phone: 408-542-5652
    1170 Morse Avenue
    Sunnyvale, CA 94089
    USA
  • Connie Kawai — Study Coordinator
    University of Southern California
    Phone: 323-442-5814
    Healthcare Consultation Building II
    1520 San Pablo Street, Suite 300
    Los Angeles, CA 90033
    USA
  • An Hao Tran — Study Coordinator
    Parkinson's & Movement Disorder Institute
    Phone: 714-378-5074
    9940 Talbert Avenue
    Suite 204
    Fountain Valley, CA 92708
    USA
  • Jessie Roth — Study Coordinator
    University of California, San Francisco
    Phone: 415-476-9276
    Parkinson's Disease Clinic & Research Center
    505 Parnassus Ave. M-798
    San Francisco, CA 94143
    USA

Connecticut

  • Tammie Kelsey — Study Coordinator
    Neurodegenerative Disorders
    Phone: 203-401-4361
    60 Temple Street, Suite 8B
    New Haven, CT 06510
    USA

Florida

  • Monica Quesada — Study Coordinator
    University of Miami
    Phone: 305-243-3647
    1501 North West 9th Avenue
    2nd Fl, Dept. of Neurology D4-5
    Miami, FL 33136
    USA
  • Holly Delgado — Study Coordinator
    University of South Florida, Movement Disorders Center
    Phone: 813-844-4453
    Movement Disorders Center
    4 Columbia Drive, Ste. 410
    Tampa, FL 33606
    USA
  • Kathryn Jemmott — Study Coordinator
    University of Florida
    Phone: 352-273-5614
    McKnight Brain Institute
    100 South Newell Drive, Room L3-100
    Gainesville, FL 32610
    USA
  • Lisa Smith — Study Coordinator
    University of Florida Jacksonville
    Phone: 904-244-9480
    580 West 8th Street
    Tower 1, 8th Floor
    Jacksonville, FL 32209
    USA
  • Helen Dunn — Study Coordinator
    VA Medical Center
    Phone: 352-376-1611
    1601 Southwest Archer Road
    Neurology Service (151)
    Gainesville, FL 32608
    USA

Georgia

  • Mary Louise Musante Weeks — Study Coordinator
    Emory University
    Phone: 404-728-4982
    Wesley Woods Health Center
    1841 Clifton Rd. Room 328
    Atlanta, GA 30329
    USA
  • Buff Dill — Study Coordinator
    Medical College of Georgia, Movement Disorders Clinic
    Phone: 706-721-0619
    Movement Disorders Clinic
    1429 Harper Street HF 1121
    Augusta, GA 30912
    USA

Hawaii

  • Stephanie Terashita — Study Coordinator
    Pacific Health Research Institute
    Phone: 808-441-5567
    405 North Kuakini
    Suite 1003
    Honolulu, HI 96817
    USA

Illinois

  • Jeana Jaglin
    Rush University Medical Center
    Phone: 312-563-2900
    Department of Neurological Sciences
    1725 West Harrison Street, Suite 755
    Chicago, IL 60612
    USA
  • Karen Williams — Study Coordinator
    Northwestern University
    Phone: 312-503-5645
    710 No. Lake Shore Dr.
    Chicago, IL 60611
    USA
  • Barbara Lokaitis — Study Coordinator
    Southern Illinois University School of Medicine
    Phone: 217-545-9737
    PO Box 19645
    Springfield, IL 62794
    USA
  • Gina Medalle — Study Coordinator
    Evanston Northwestern Healthcare
    Phone: 847-657-5875
    Department of Neurology
    2100 Pfingsten Road, Ste. B110
    Glenview, IL 60026
    USA

Indiana

  • Joann Belden — Study Coordinator
    Indiana University School of Medicine
    Phone: 317-278-0868
    Outpatient Clinical Research  Clinical ResearchPatient-oriented research conducted with human participants (or on material of human origin such as tissues and specimens) for which an investigator directly interacts with human participants. This area of research includes: mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Facility
    535 Barnhill Drive Room 150
    Indianapolis, IN 46202
    USA

Kansas

  • Tamara Gales — Study Coordinator
    University of Kansas Medical Center
    Phone: 913-588-5250
    3599 Rainbow Blvd.
    Department of Neurology Mail Stop # 2012
    Kansas City, KS 66160
    USA

Kentucky

  • Renee Wagner — Study Coordinator
    University of Kentucky Clinical Research
    Phone: 859-323-0028
    C201 Kentucky Clinic
    740 Limestone Street
    Lexington, KY 40536
    USA

Louisiana

  • Maureen Cook — Study Coordinator
    Ochsner Clinic Foundation
    Phone: 504-842-2487
    1514 Jefferson Highway
    Dept. of Neurology, 7th Floor
    New Orleans, LA 70121
    USA
  • Colette Hilliard — Study Coordinator
    LSU Health Science Center Shreveport
    Phone: 318-675-8157
    1501 Kings Highway
    Room 3-436
    Shreveport, LA 71130
    USA

Massachusetts

  • Lewis Sudarsky — Study Coordinator
    Brigham & Women's Hospital
    Phone: 617-732-5405
    Neurology Department ASB2
    75 Francis Street
    Boston, MA 02115
    USA
  • Peggy Rose — Study Coordinator
    Beth Israel Deaconess Medical Center
    Phone: 617-667-9885
    330 Brookline Avenue
    Shapiro 809D
    Boston, MA 02215
    USA

Maryland

  • Becky Dunlop — Study Coordinator
    Johns Hopkins University
    Phone: 410-955-8795
    601 North Caroline Street
    Suite 5064
    Baltimore, MD 21287
    USA
  • Kelly Dustin — Study Coordinator
    University of Maryland School of Medicine
    Phone: 410-328-7809
    Department of Neurology
    22 South Greene Street, N4W46
    Baltimore, MD 21201
    USA

Michigan

  • Kristine Wernette — Study Coordinator
    University of Michigan
    Phone: 734-936-5894
    1500 E. Medical Center Drive
    B1 H202 Nuclear Medicine
    Ann Arbor, MI 48109
    USA
  • Doozie Snider — Study Coordinator
    Michigan State University
    Phone: 517-353-8122
    Department of Neurology
    A217 Clinical Center, 138 Service Road
    East Lansing, MI 48824
    USA

Minnesota

  • Susan Peterson — Study Coordinator
    Struthers Parkinson's Center
    Phone: 952-993-2249
    6701 Country Club Drive
    Golden Valley, MN 55427
    USA

Missouri

  • Patricia Deppen — Study Coordinator
    Washington University School of Medicine
    Phone: 314-362-8548
    660 South Euclid Avenue
    campus 8111
    St. Louis, MO 63110
    USA

North Carolina

  • Joanne Field — Study Coordinator
    Duke University Medical Center
    Phone: 919-668-2842
    Duke Health Center at Morreene Road
    932 Morreene Road Room 213
    Durham, NC 27705
    USA

New Hampshire

  • Pauline R. Leblanc — Study Coordinator
    Dartmouth Hitchcock Medical Center
    Phone: 603-650-4165
    One Medical Center Drive
    2 Buck Road
    Lebanon, NH 03756
    USA

New Jersey

  • Emily Kosa — Study Coordinator
    UMDNJ Robert Wood Johnson Medical School
    Phone: 732-235-8971
    Department of Neurology
    Suite 6100, 125 Patterson Street
    New Brunswick, NJ 08901
    USA

New York

  • Nita Gardiner
    Primary Study Coordinator
    Nita.Gardiner@ctcc.rochester.edu
    Phone: 585-341-7569
    NY
    USA
  • Barbara Shannon — Study Coordinator
    Northshore-LIJ Health System
    Phone: 516-562-2905
    The Feinstein Institute FPR Medical Research
    350 Community Drive
    Manhasset, NY 11030
    USA
  • Elizabeth Hayes — Study Coordinator
    SUNY Downstate Medical Center
    Phone: 718-270-2945
    450 Clarkson Avenue, Dept. of Neurology
    Box 1213
    Brooklyn, NY 11203
    USA

Oregon

  • Stephanie Crocker — Study Coordinator
    OHSU Oregon Health & Science University, Dept. of Neurology
    Phone: 503-418-1769
    Department of Neurology
    3181 South West Sam Jackson Park Road
    Portland, OR 97239
    USA

Pennsylvania

  • Sue Reichwein — Study Coordinator
    University of Pennsylvania, Pennsylvania Hospital
    Phone: 215-829-7273
    Pennsylvania Hospital, Penn Neurological Institute
    330 South Ninth Street
    Philadelphia, PA 19107
    USA
  • Stephanie Sendek — Study Coordinator
    Thomas Jefferson University
    Phone: 215-955-8700
    1015 Chestnut Street
    Suite 520
    Philadelphia, PA 19107
    USA
  • Gwyn M. Vernon — Study Coordinator
    Thomas Jefferson University/Lankenau Hospital
    Phone: 610-642-5371
    Lankenau Medical Building
    Suite 161 East, 100 Lancaster Avenue
    Wynnewood, PA 19096
    USA

Rhode Island

  • Margaret Lannon — Study Coordinator
    Neurohealth Parkinson's Disease
    Phone: 401-921-4245
    Movement Disorder Center
    227 Centerville Rd.
    Warwick, RI 02886
    USA

South Carolina

  • Vicky Salak — Study Coordinator
    Medical University of South Carolina
    Phone: 843-792-7262
    Charleston Memorial Hospital
    326 Calhoun Street, Suite 308
    Charleston, SC 29401
    USA

Tennessee

  • Dorothy Shearon — Study Coordinator
    Vanderbilt University Medical Center
    Phone: 615-936-0219
    2311 Pierce Avenue
    Room 2217
    Nashville, TN 37212
    USA

Texas

  • Christine Hunter — Study Coordinator
    Baylor College of Medicine
    Phone: 713-798-3951
    6550 Fannin
    Suite 1801
    Houston, TX 77030
    USA
  • Brigid Hayward — Study Coordinator
    University of Texas Southwestern Medical Center at Dallas
    Phone: 214-648-7976
    5323 Harry Hines Boulevard
    H1-108
    Dallas, TX 75390
    USA

Virginia

  • Elke Rost-Ruffner — Study Coordinator
    University of Virginia, Department of Neurology
    Phone: 434-243-5422
    Department of Neurology
    500 Ray C. Hunt Drive
    Charlottesville, VA 22903
    USA

Vermont

  • Shannon Lenox — Study Coordinator
    University of Vermont, Dept. of Neurology
    Phone: 802-656-3876
    Department of Neurology, Given Building C-219
    89 Beaumont Avenue
    Burlington, VT 05405
    USA

Individual Contacts and Locations

Colorado

  • Jacci Bainbridge — Study Coordinator
    University of Colorado Health Sciences Center
    Phone: 303-315-2502
    Health Sciences Center
    4200 East 9th Street, Campus Box C238, Dept. of Clinical Pharmacy
    Denver, CO 80262
    USA

View All Locations and Contacts


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