Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT00873392
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT00873392
Study Brief:
Protocol Section:
NCT00873392