Timing of Levodopa Treatment in Parkinson's Disease - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Timing of Levodopa Treatment in Parkinson's Disease

Official Title ^†

Earlier Versus Later L-Dopa in Parkinson's Disease

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Parkinson's Disease

Intervention ^†

Drug: levodopa

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

January 1998

Completion Date

February 2004

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

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00004733

Organization ID

R01NS34796

Secondary IDs ^††

Study Sponsor ^†

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators ^††

Investigators ^†

Principal Investigator:

Stanley Fahn

Columbia University Health Sciences

Information Provided By

National Institute of Neurological Disorders and Stroke (NINDS)

Verification Date

February 2004

First Received Date ^†

February 25, 2000

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.