Parkinson's Disease Clinical Trials For posting and discussion of clinical trials related to Parkinson's Disease, and for the Parkinson Pipeline Project. All are welcome.


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Old 05-31-2007, 05:56 PM #1
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Arrow CLINICAL TRIAL...PHASE III...NET-PD LS-1 Creatine

NET-PD LS-1 Creatine in Parkinson’s Disease - Recruiting 1,720 Participants!

Official Study 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)

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Study ID: (none)

Trial Start Date: 22 Mar 2007
Last Updated Date: 21 May 2007

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, 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 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 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.

Enrollment
Expected Enrollment: 1720

Trial Phase
Study Phase: Phase 3 (About Phases)

Symptoms
# Trial does not treat PD symptoms

Time Commitment

Length of Time Commitment: More than six months
Frequency of office visits: At least 9 follow-up clinic visits and at least 3 telephone calls within a minimum of 5 years

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 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.
Primary Contact
Debbie Fraser & Nita Gardiner
Primary Study Coordinators
Phone : 585-273-4266
Debbie.Fraser@ctcc.rochester.edu
NY
USA

Local Contacts
Lorelei Derwent
Study Coordinator
University of Calgary Movement Disorders Program
Phone : 403-220-8413
Dept. of Clin. Neurosciences
Area 3 Neurology, 3350 Hospital DR NW Health Sciences Centre
Calgary, AB T2N4N
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 T5G0B
Canada

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

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

An Hao Tran
Study Coordinator
Parkinson's & Movement Disorder Institute
Phone : 714-378-5074
9940 Talbert Avenue
Suite 204
Fountain Valley, CA 92708
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

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

Katie Ersted
Study Coordinator
The Parkinson's Institute
Phone : 408-542-5652
1170 Morse Avenue
Sunnyvale, CA 94089
USA

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

Helen Dunn
Study Coordinator
VA Medical Center
Phone : 352-376-1611
1601 Southwest Archer Road
Neurology Service (151)
Gainesville, FL 32608
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

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

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

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

Karen Williams
Study Coordinator
Northwestern University
Phone : 312-503-5645
710 No. Lake Shore Dr.
Chicago, IL 60611
USA

Jeana Jaglin
Rush University Medical Center
Phone : 312-563-2900
Department of Neurological Sciences
1725 West Harrison Street, Suite 755
Chicago, IL 60612
USA

Gina Medalle
Study Coordinator
Evanston Northwestern Healthcare
Phone : 847-657-5875
Department of Neurology
2100 Pfingsten Road, Ste. B110
Glenview, IL 60026
USA

Barbara Lokaitis
Study Coordinator
Southern Illinois University School of Medicine
Phone : 217-545-9737
PO Box 19645
Springfield, IL 62794
USA

Joann Belden
Study Coordinator
Indiana University School of Medicine
Phone : 317-278-0868
Outpatient Clinical Research Facility
535 Barnhill Drive Room 150
Indianapolis, IN 46202
USA

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

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

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

Linda Paul
Study Coordinator
Beth Israel Deaconess Medical Center
Phone : 617-667-9885
330 Brookline Avenue
Shapiro 809D
Boston, MA 02215
USA

Lewis Sudarsky
Study Coordinator
Brigham & Women's Hospital
Phone : 617-732-5405
Neurology Department ASB2
75 Francis Street
Boston, MA 02115
USA

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

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

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

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

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

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

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

Nita Gardiner
Primary Study Coordinator
Phone : 585-341-7569
Nita.Gardiner@ctcc.rochester.edu
NY
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

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

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

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

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

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

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

Christine Hunter
Study Coordinator
Baylor College of Medicine
Phone : 713-798-3951
6550 Fannin
Suite 1801
Houston, TX 77030
USA

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

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

Trial Start Date: 22 Mar 2007
Last Updated Date: 21 May 2007

Trial Post date: 18 May 2007
Website Url: http://www.parkinsontrial.ninds.nih.gov/

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Full Details
:

PDTrials.org http://www.pdtrials.org/front/trial_...p?trial_id=161ClinicalTrials.gov http://clinicaltrials.gov/ct/show/NCT00427674?order=1[LIST][*]Complete list of PD trials

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Parkinson Pipeline Project
www.pdpipeline.org
Following theapies from pre-clinical development to approval in the Parkinson Pipeline Project Database (see homepage for link to database)

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I long to accomplish a great and noble tasks, but it is my chief duty to accomplish humble tasks as though they were great and noble. The world is moved along, not only by the mighty shoves of its heroes, but also by the aggregate of the tiny pushes of each honest worker. ~~Helen Keller

Last edited by Stitcher; 05-31-2007 at 06:45 PM.
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Old 06-06-2012, 12:01 PM #2
Diego24
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So what happened to this study ? Did it start in 2007 or later ? I saw today that they expect the study to be finished in 2015 !!! That's still a looooong way to go. Anyone involved in this clinical trial ? I guess if the study started in 2007 the results must at least not be too bad because they didn't stop the clinical trial like they did with Coq10 clinical trials ... ?
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