Status:
COMPLETED
Pilot Trial of Transnasal Nicotine in Parkinson Disease
Lead Sponsor:
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Collaborating Sponsors:
Howard University
Conditions:
Parkinson Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Parkinson's disease (PD), the second most common progressive neurodegenerative disorder, is associated with loss of dopaminergic neurons in the substantia nigra pars compacta that leads to striatal do...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03865121
Start Date
March 4 2019
End Date
November 2 2019
Last Update
November 6 2019
Active Locations (1)
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1
Instituto Nacional de Neurología y Neurocirugía MVS
Mexico City, Mexico, 14269