Timing of Levodopa Treatment in Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT00004733
First received: February 25, 2000
Last updated: June 23, 2005
Last verified: February 2004
  Purpose

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).


Condition Intervention Phase
Parkinson's Disease
Drug: levodopa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Earlier Versus Later L-Dopa in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Study Start Date: January 1998
Estimated Study Completion Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004733

Locations
United States, New York
Columbia University Health Sciences
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: Stanley Fahn Columbia University Health Sciences
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004733     History of Changes
Other Study ID Numbers: R01NS34796
Study First Received: February 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
Parkinson's
ELLDOPA
L-dopa
levodopa
Sinemet
tremor

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Levodopa
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014