Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
Medical treatment of idiopathic Parkinson disease motor symptoms requires dopaminergic drugs,
with long term disabling side effects. (fluctuations, dyskinesia, ON/OFF phenomena). Use of
nicotine in Parkinson's disease has been suggested by the lowest prevalence of smokers among
Parkinsonian patients. However, controlled studies provided conflicting results. One of our
patients showed a substantial decrease of his parkinsonian symptoms under transdermal
nicotine-therapy. Currently, this patient has been treated since 8 years with an excellent
safety, especially on cardiovascular level. Otherwise, the investigators performed an open
pilot safety and feasibility study in 6 patients, which demonstrated the possibility of a
controlled study. In this study, all patients received daily doses during several months
until 105 mg/day and could, in parallel, decrease their L-Dopa and agonists doses, improving
their motor scores.
The investigators now propose a phase II, controlled, single blind and randomised efficacy
study (n=40) in 2 parallel groups. (1 group transdermal nicotine-therapy / 1 control group
without additional therapy) The main objective is to verify the correlation between UPDRS
(score III) motor score and the administrated nicotine dose. This study will also allow the
evaluation of nicotine neuroprotective effect. The incrementation phase by weekly steps of 5
mg until 20 mg, then 10 mg to reach 90 mg/j or the maximal tolerated dose, will last on 11
weeks and will be followed by a 28 weeks phase at this stable dose. After this maximal dose
"plateau phase", treatment will be progressively decreased by 15 mg weekly steps, over a de
6-week period followed by a five-week wash out phase.
Taking into account results from the pilot study, a long-term high doses treatment, seems to
be liable to improve patients who deeply suffer from their disease. This is why the
investigators now propose this monocentric institutional project.