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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03865121
Date of registration: 26/02/2019
Prospective Registration: Yes
Primary sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Public title: Pilot Trial of Transnasal Nicotine in Parkinson Disease
Scientific title: Uncontrolled Pilot Trial of Transnasal Nicotine in Parkinson Disease
Date of first enrolment: March 4, 2019
Target sample size: 6
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03865121
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Mexico
Contacts
Name:     Mayela Rodríguez Violante, MSc.
Address: 
Telephone:
Email:
Affiliation:  El Instituto Nacional de Neurologia Manuel Velasco Suarez
Key inclusion & exclusion 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



Age minimum: 60 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson Disease
Intervention(s)
Drug: Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY)
Primary Outcome(s)
Change from in motor dysfunction as assessed by MDS-UPDRS (Movement Disorder Society Unified Parkinson Disease subscale 3, range 0 best -56 worse ). [Time Frame: 1 month]
Secondary Outcome(s)
Secondary ID(s)
INNNMVS
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Howard University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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