Parkinson’s & Movement Disorder Institute

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THE ELLDOPA STUDY
EARLIER VS. LATER L-DOPA IN PARKINSON'S DISEASE

The study is a multicenter, double blind clinical trial in outpatients. It is designed to determine whether earlier vs. later introduction (and moderate vs. low dosage) of Levodopa to patients with Parkinson's disease is beneficial or harmful. It is intended to answer the concern raised by clinicians and patients regarding Parkinson's disease (PD), namely, should the introduction of L-dopa be delayed as long as clinically feasible or should it be employed early to improve quality of life.

Levodopa is considered the 'gold standard' of symptomatic therapy because it is the most effective drug in controlling parkinsonian symptoms. However, there is uncertainty about whether it may be harmful in the long run. First, because of concerns that its metabolites might increase oxidant stress and thereby hasten progression of Parkinson's disease, and second, because it might lead to earlier introduction of clinical fluctuations of motor response and unpleasant dyskinesias.

The initial study visit consists of screening tests, medical history, and physical examination. Patients meeting the inclusion/exclusion criteria and screening test requirements of the protocol will be randomized to receive either active study drug or placebo and will be seen weekly during the treatment phase. All study medications, office visits, physical examinations, screening and laboratory tests are provided.

Inclusion / Exclusion Criteria

A. Inclusion Criteria

1. The presence of idiopathic Parkinson's disease, with at least two of the following three cardinal signs (resting tremor, bradykinesia, rigidity) being present, and without any other known or suspected cause of parkinsonism.
2. Adults, 30 years or older, with onset of symptom after the age of 29. Both men and women in all ethnic groups are eligible to participate. Women of child-bearing age will not be excluded.
3. Parkinson's rating scale 1, 1.5, 2.0, or 2.5, representing the stage of unilateral involvement (stage 1.0 and 1.5) and mild bilateral or mid line involvement without impairment of balance (Stage 2.0 and 2.5)
4. Duration from time of diagnosis < 2 years.

B. Exclusion Criteria

1. Those with an identifiable cause of Parkinsonism by history, examination, or laboratory testing. Specifically there will be no history of multiple strokes, encephalitis, oculogyric crisis, remission, or exposure to toxicants or to recent neuroleptics. Patients with supranuclear gaze paresis, extensor plantar responses, cerebellar signs, dementia (score of 25 or lower out of 30 on the minimental state test, or symptomatic or prominent orthostatic hypotension (mean arterial pressure drop > 25 mm Hg on standing) will be excluded. Exposure to neuroleptics for non-psychotic usage (e.g. metoclopramide for gastrointestinal problems) without persistent extrapyramidal sequelae would not exclude patients if the interval between exposure and enrollment was greater than 6 months.
2. Those with a UPDRS tremor score in any limb of 3.0 severity or greater.
3. The presence of either freezing (motor blocks) or loss of postural reflexes.
4. Those taking or requiring any antiparkinson medications and patients expected (by the investigator) to require symptomatic antiparkinsonian therapy within 6 months.
5. Prior exposure to any levodopa preparation or dopamine agonist.
6. Prior exposure to amantadine, anticholinergics and antihistamines is permitted within one month prior to entry into the study.
7. Exposure to selegiline or other irreversible monoamine oxidase inhibitors within 4 months of enrollment.
8. Exposure to dopamine receptor blocking agent, including calcium channel blockers, cinnarizine and flunarizine within the past 6 months of enrollment.
9. Unstable medical condition or history of drug abuse.
10. Major depression (Halmilton score > 19) Those with a medical history of medical malignant melanoma.