Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-28 @ 12:09 PM
Study NCT ID:
NCT00873392
Status:
COMPLETED
Last Update Posted:
2013-12-31
First Post:
2009-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease(One Daily Administration).A Controlled Randomised Study, in Two Parallel Groups and Single Blind in 40 Patients.
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NICOPARK2
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 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.
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.
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 therapy (N= 20).
This study will consist in :
* One phase of weekly incrementations of dose during 11 weeks,
* Steps of 5 mg until 20 mg
* Then steps of 10 mg until the dose of 90mg or the maximal tolerated dose
* One stable dose phase, (90 mg or maximal tolerated dose) during 28 weeks,
* One phase of decrementing: treatment will be progressively decreased in a 6 weeks period,
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 therapy (N= 20).
This study will consist in :
* One phase of weekly incrementations of dose during 11 weeks,
* Steps of 5 mg until 20 mg
* Then steps of 10 mg until the dose of 90mg or the maximal tolerated dose
* One stable dose phase, (90 mg or maximal tolerated dose) during 28 weeks,
* One phase of decrementing: treatment will be progressively decreased in a 6 weeks period,
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: