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Efficacy and Safety of Stalevo® in Patients with Parkinson's Disease Requiring Initiation of Levodopa Therapy - Article


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Parkinson's Disease

Lewy Body Disease; Parkinson disease; Parkinson//'s disease; PD - Parkinson's disease; Primary Parkinsonism; Shaking Palsy 




Clinical Trial: Efficacy and Safety of Stalevo® in Patients with Parkinson's Disease Requiring Initiation of Levodopa Therapy

This study is currently recruiting patients.

Sponsors and Collaborators: Novartis Pharmaceuticals
Orion Pharma
Information provided by: Novartis Pharmaceuticals

Purpose

The purpose of this study is to demonstrate that when used as initial levodopa therapy, Stalevo® results in a delay in the time of development of incident dyskinesia.

Condition Treatment or Intervention Phase
Parkinson's Disease
 Drug: Stalevo® (carbidopa, levodopa, entacapone)
Phase III

MedlinePlus related topics:  Parkinson's Disease
Genetics Home Reference related topics:  Parkinson disease

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 
Primary Outcomes: Time of onset of dyskinesia

Study start: September 2004

Eligibility

Ages Eligible for Study:  30 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria:

  • History and or signs and or symptoms of atypical or secondary parkinsonism
  • Presence at visit 1 of wearing-off symptoms, dyskinesia or other motor complications
  • Levodopa exposure of more than 30 days or anytime within 8 weeks prior to visit 1

Location and Contact Information

ELC trial team       ELC.200@pharma.novartis.com

Alabama
      Birmingham,  Alabama,  35233,  United States; Not yet recruiting

Arizona
      Scottsdale,  Arizona,  85259,  United States; Not yet recruiting

      Phoenix,  Arizona,  85006,  United States; Not yet recruiting

California
      Los Angeles,  California,  90033,  United States; Not yet recruiting

      La Jolla,  California,  92037,  United States; Recruiting

      Sunnyvale,  California,  94089,  United States; Recruiting

Connecticut
      New Haven,  Connecticut,  06510,  United States; Recruiting

Florida
      Miami,  Florida,  33136,  United States; Not yet recruiting

      Tampa,  Florida,  33606,  United States; Recruiting

Georgia
      Atlanta,  Georgia,  30329,  United States; Not yet recruiting

      Augusta,  Georgia,  30912,  United States; Not yet recruiting

Illinois
      Chicago,  Illinois,  60612,  United States; Not yet recruiting

Kansas
      Kansas City,  Kansas,  66160,  United States; Not yet recruiting

Louisiana
      New Orleans,  Louisiana,  70112,  United States; Not yet recruiting

Massachusetts
      Boston,  Massachusetts,  02118,  United States; Not yet recruiting

Michigan
      Southfield,  Michigan,  48030,  United States; Recruiting

New York
      Albany,  New York,  12205,  United States; Recruiting

      Rochester,  New York,  14618,  United States; Not yet recruiting

      New York,  New York,  10029,  United States; Not yet recruiting

North Carolina
      Durham,  North Carolina,  27705,  United States; Recruiting

Pennsylvania
      Philadelphia,  Pennsylvania,  19107,  United States; Not yet recruiting

Rhode Island
      Pawtucket,  Rhode Island,  02860,  United States; Recruiting

Tennessee
      Memphis,  Tennessee,  38163,  United States; Not yet recruiting

Texas
      Houston,  Texas,  77030,  United States; Recruiting

      Dallas,  Texas,  75390,  United States; Recruiting

Wisconsin
      Milwaukee,  Wisconsin,  53233,  United States; Recruiting

Austria
      Innsbruck,  6020,  Austria; Not yet recruiting

Belgium
      Antwerp,  2020,  Belgium; Recruiting

Canada, Alberta
      Edmonton,  Alberta,  T5G 0B7,  Canada; Recruiting

Canada, Ontario
      London,  Ontario,  N6A 5A5,  Canada; Recruiting

      Toronto,  Ontario,  M5T 2S8,  Canada; Recruiting

Canada, Quebec
      Verdun,  Quebec,  H4H 1R3,  Canada; Recruiting

France
      Nantes,  44093,  France; Not yet recruiting

      Paris,  75651 Cedex 13,  France; Not yet recruiting

      Toulhouse,  31059,  France; Not yet recruiting

      Lille,  59037 Cedex,  France; Not yet recruiting

Greece
      Ioannina,  45500,  Greece; Not yet recruiting

      Thessalon,  54363,  Greece; Not yet recruiting

Italy
      Napoli,  80131,  Italy; Not yet recruiting

      Camaiore,  55043,  Italy; Not yet recruiting

      Roma,  133,  Italy; Not yet recruiting

      Pozzilli,  86077,  Italy; Not yet recruiting

Spain
      Barcelona,  08036,  Spain; Not yet recruiting

      Madrid,  28035,  Spain; Not yet recruiting

Switzerland
      Lausanne,  1011,  Switzerland; Not yet recruiting

Turkey
      Istanbul,  34390 Capa,  Turkey; Not yet recruiting

More Information

Study ID Numbers:  ELC200A2401
Record last reviewed:  January 2005
Last Updated:  January 13, 2005
Record first received:  December 10, 2004
ClinicalTrials.gov Identifier:  NCT00099268
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: May 11, 2006
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