Status:
COMPLETED
Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Idiopathic Parkinson's Disease
Eligibility:
All Genders
35-70 years
Phase:
PHASE2
Brief 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 Pa...
Detailed Description
Experimental plan Phase II controled study, in 40 patients, randomised in single blind, and in 2 groups: * One group treated by transdermal nicotine-therapy (N= 20), * One group without additional t...
Eligibility Criteria
Inclusion
- Patients with idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB), since at least three years,or treated by L-dopa for 2 years minimum with motor fluctuations (amendment 12/10/2010)
- Patients aged between 35 and 70 years inclusive,
- L-Dopa responders: L-Dopa test with an improvement of over 30 % of UPDRS-III motor score,
- L-Dopa treatment since at least three years,
- Patients with Parkinson's disease stage maximum IV ("OFF" state) according to the modified Hoehn and Yahr classification (without treatment since at least 12 hours), and III maximum in "ON" state,
- Non smoker,
- Signed Informed Consent
Exclusion
- Previous neurosurgery for Parkinson's disease,
- Weight \< 45 kg or \> 100 kg,
- Previous Parkinson's disease treatment by transdermal nicotine-therapy discontinued less than 6 months before inclusion,
- History of allergy to Nicotine,
- History of allergy to transdermal device,
- Cutaneous disorders wich could disturb use of transdermal device,
- Cognitive disorders, (Mattis score \< 125)
- History or detection at inclusion of cardiac arrhythmia,
- History of coronary failure,
- History of cardiac failure, (NYHA from II to IV \& ejection fraction (EF) \< 40%)
- Severe arterial hypertension (diastolic \> 100 mmHg) or uncontrolled,
- Symptomatic orthostatic hypotension, (2 points of differential in standing position and systolic \<100mm Hg or clinical evidence)
- History of stroke or occlusive peripheral vascular disease,
- History of hyperthyroid,
- History or detection at inclusion of type I or II diabetes, (HbA1c \< 11%)
- History of pulmonary disease: asthma, chronic obstructive pulmonary disease (COPD),
- History of auto-immune disease,
- Progressive depression, suicide attack, acute psychosis, invasive hallucinations, psychiatrist opinion harmful for a correct compliance to experimentation,
- History or recent gastroduodenal ulcer, (\< 3 months)
- History or detection at inclusion of hepatobiliary or renal failure, (clearance\< 60 mL/min)
- Pregnancy, breast-feeding,
- Absence of effective contraception in women in childbearing potential,
- Treatment by nifedipine, beta-blockers, diuretics, insulin and H2 antihistaminics for potential side effects in combination with nicotine,
- Patients unlikely to be compliant or to fully cooperate during the study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00873392
Start Date
February 1 2009
End Date
May 1 2013
Last Update
December 31 2013
Active Locations (1)
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1
Groupe Hospitalier Albert Chenevier Henri Mondor
Créteil, France, 94000