Timing of Levodopa Treatment in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
levodopa
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's, ELLDOPA, L-dopa, levodopa, Sinemet, tremor
Eligibility Criteria
Inclusion Criteria: Early, mild PD, not requiring medications Age 30 or older Duration from time of diagnosis of PD: less than 2 years Hoehn & Yahr Stage 1 or 2 Exposure to levodopa or dopamine agonist of 14 days or less
Sites / Locations
- Columbia University Health Sciences
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004733
First Posted
February 25, 2000
Last Updated
June 23, 2005
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00004733
Brief Title
Timing of Levodopa Treatment in Parkinson's Disease
Official Title
Earlier Versus Later L-Dopa in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2004
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
5. Study Description
Brief Summary
The ELLDOPA study is a controlled clinical trial in patients with newly diagnosed PD to determine the optimal timing and dosing with levodopa (Sinemet or its generic equivalents).
Detailed Description
The time to begin levodopa therapy has been controversial for many years, and yet every patient with PD, along with his/her treating doctor, needs to make this decision. One school of thought is that levodopa may lead to developing motor fluctuations and involuntary movements, and therefore its introduction should be delayed. The opposing school of thought argues that it is the worsening severity of the disease over time that makes the patient susceptible to these problems, and argues that the best response to levodopa is in the early stages of the illness when an improved quality of life can be optimized with levodopa.
Another debated issue is whether levodopa offers protection or is harmful to the remaining dopamine neurons. The latest studies in tissue culture show that when glia (the brain's supportive cells) tissue is present in addition to the nerve cells, the glia tissue becomes protective against any levodopa toxicity. Because glia tissue is present in brain, the argument has been made that levodopa should not be toxic in living brain tissue. A few studies have been carried out in animal models of PD. Two of these animal studies suggest levodopa is toxic to neurons, and two show that levodopa is not toxic and may actually have a protective effect. So there is no convincing or consistent evidence that levodopa damages dopamine neurons in humans or animal models of PD.
With this uncertainty as to what levodopa may be doing to the remaining dopamine cells in patients with PD, there is a strong need to make the determination in patients as to whether levodopa protects or worsens the progression of PD.
Primary End Point: Progression of PD as determined by change in a PD rating scale, the UPDRS, between baseline examination and examination at Week 42. These two examinations are conducted by a Primary Rater who sees the subjects only twice: at baseline and at Week 42, so as not to be influenced by any effects the subject may have experienced during the 40 week exposure to investigational medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's, ELLDOPA, L-dopa, levodopa, Sinemet, tremor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
levodopa
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Early, mild PD, not requiring medications
Age 30 or older
Duration from time of diagnosis of PD: less than 2 years
Hoehn & Yahr Stage 1 or 2
Exposure to levodopa or dopamine agonist of 14 days or less
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley Fahn
Organizational Affiliation
Columbia University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Health Sciences
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Timing of Levodopa Treatment in Parkinson's Disease
We'll reach out to this number within 24 hrs