ELLDOPA

 

This study has completed enrollment.

ANNOUNCEMENT

SEEKING SUBJECTS...CAN YOU HELP?

Testing Levodopa's Effect on Progression of Parkinson's Disease

A NORTH AMERICAN STUDY BY THE PARKINSON STUDY GROUP

THE FOLLOWING INFORMATION EXPLAINS THE PURPOSE AND DESIGN OF THE ELLDOPA STUDY:

There are 34 study sites throughout the USA and Canada. We need 360 subjects with a diagnosis of Parkinson's disease of: less than 2 years since diagnosis, Hoehn & Yahr Stage 1 or 2, and less than or equal to 14 day exposure to levodopa or a dopamine agonist The last criterion makes recruitment especially hard. That is why we need the help of all neurologists who are interested in answering the question whether levodopa enhances progression, slows progression, or does not influence progression of PD. In this controlled clinical trial, subjects are randomized to one of four treatment arms (90 subjects in each arm): Placebo Carbidopa/levodopa 12.5/50 mg tid Carbidopa/levodopa 25/100 mg tid Carbidopa/levodopa 50/200 mg tid and followed for 40 weeks (9 months), AND a 2-week period of no medications.   PRIMARY END POINT: Progression of PD as determined by change in UPDRS between baseline examination and examination at Week 42. These two examinations are conducted by a Primary Rater who sees the subject 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. PLEASE GIVE YOUR PATIENTS WHO ARE SUITABLE SUBJECTS THE ATTACHED 2-PAGE FLYER: "THE ELLDOPA STUDY". (PLEASE PHOTOCOPY IT FOR DISTRIBUTION FOR PROSPECTIVE SUBJECTS.) IF THEY ARE INTERESTED, REFER THEM TO THE ELLDOPA ADMINISTRATOR, LYDIA REYES, AT 212-305-8015, WHO WILL INFORM THEM OF THE MOST CONVENIENT STUDY SITE TO VISIT. THANK YOU.   The ELLDOPA Study: Why the study is important, and how patients can help answer the question of what is the best dose and timing of starting levodopa therapy in Parkinson's disease. The Parkinson Study Group (PSG) is the consortium of academic neurologists specializing in the care of patients with Parkinson's disease (PD) and conducting controlled clinical trials to determine better therapies for this disorder. The PSG has been awarded a grant from the National Institutes of Health to conduct a controlled clinical trial in patients with newly diagnosed PD to determine the optimal timing and dosing with levodopa (Sinemet or its generic equivalents). The time when 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 tissue (the brain's supportive cells) is present in addition to the nerve cells, the glia tissue becomes protective against any levodopa toxicity. Because glia tissue is present in the brain, the argument has been made that levodopa should no 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 PD. This is a very important question in the treatment of PD, and the PSG has, therefore, developed the ELLDOPA (Earlier vs. Later L-DOPA) study to determine the dose and timing for introducing levodopa. The study began to enroll individuals into the trial in October, 1998. Listed here are the inclusion criteria and the general outline of the study. The PSG is seeking patients with early PD who are interested in participating in clinical research to answer this important question. DESIGN OF THE STUDY The ELLDOPA study is a double-blind study that lasts 9 1/2 months (42 weeks). On entering the study, the individual is assigned to one of four treatment arms. Neither the patient nor doctors know to which of the four treatments the patient has been assigned. The dose of medication is built up over a 9-week period. Then, the patient remains on the assigned dose for another 31 weeks, at which time the medication is withdrawn in order to determine the clinical status of the illness without medicines being taken. Because levodopa's effect fades slowly, there is a 2-week period without the medicines (withdrawl phase), and then the patient is examined again. There are a total of eight visits during the 42 weeks of the study. THE FOUR TREATMENT ARMS A. Placebo group B. Tiny dose dopa group = levodopa 50 mg t.i.d. C. Low dose dopa group = levodopa 100 mg t.i.d. D. Medium dose dopa group = levodopa 200 mg t.i.d. FREQUENCY OF VISITS Screening (blood tests and EKG) 0: Baseline 1-28 days later to start the study medication 1: end of week 3 (plus or minus) 3 days 2: end of week 9 (plus or minus) 3 days 3: end of week 24 (plus or minus) 7 days 4: end of week 40 (plus or minus) 7 days 5: end of week 41 (plus or minus) 1 day 6: end of week 42 (plus or minus) 1 day COST TO SUBJECTS None. Drugs and examinations will be free. INCLUSION CRITERIA A. Early, mild PD, not requiring medications B. Age: 30 or older C. Duration from time of diagnosis of PD: less than 2 years D. Less than or equal to 14 day exposure to levodopa or dopamine agonist This study has completed enrollment.