Pilot Trial of Transnasal Nicotine in Parkinson Disease
Status:
Completed
Trial end date:
2019-11-02
Target enrollment:
Participant gender:
Summary
The widely observed inverse relationship between smoking and Parkinson's Disease (PD) and the
results of numerous preclinical studies indicating neuroprotective effects of nicotine,
suggest a possible novel intervention in PD. In our opinion, an optimal nicotinic therapy in
PD would consist of pulsatile nicotine delivery (e.g. via nasal spray) similar to pulsatile
nicotine obtained via smoking. The investigators believe that pulsatile stimulation of the
central nicotinic receptors (achievable via nasal spray) would affect the dynamic of the
nicotinic receptors much more desirably and similar to smoking compared to continuous
nicotine administration via patch, which might result in continuous nicotinic receptor
desensitization. Thus, this pilot trial seeks to evaluate the efficacy of nicotine nasal
spray (Nicotrol NS®) in symptomatology of PD. For this purpose, a total of 6 non-smoking
patients at intermediate disease stages (2-3 of Hoehn and Yahr scale) and receiving
conventional therapy for PD will be recruited at the "Instituto Nacional de Neurología y
Neurocirugía, (Manuel Velasco Suárez)" in Mexico City. Nicotrol NS® in incremental dosing (up
to 10 mg/day) regimens will be added to the current medications to each patient during the
first week. This will be maintained for up to 1 month. Motor and non-motor aspects of PD will
be evaluated. The investigators expect significant improvement of motor and non-motor
symptoms in all patients receiving Nicotrol NS® during therapy and a reversal during
withdrawal.
Phase:
Phase 2
Details
Lead Sponsor:
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez