Pilot Trial of Transnasal Nicotine in Parkinson Disease

• Status: Completed
• Trial end date: 2019-11-02
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
• Collaborator: Howard University
• Treatments: Nicotine

Criteria

Inclusion criteria:

• Subjects over 60 years of age with a clinical diagnosis of Parkinson's disease

• Stages of the disease 2-3 of Hoehn and Yahr

• Not exposed to tobacco during any stage of their life

• No history of lung diseases

• No laboratory abnormalities

• No history of adverse reactions to nicotine

• Able to use nicotine nasal spray

• Residents of Mexico City able to attend for evaluations

• Under current treatment with levodopa at a stable dose

• Not currently receiving a monoamine oxidase inhibitor treatment

Exclusion Criteria

• Unable to complete follow-up protocol

• Drug adverse reaction

• Death