Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03865121 |
Date of registration:
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26/02/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Pilot Trial of Transnasal Nicotine in Parkinson Disease
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Scientific title:
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Uncontrolled Pilot Trial of Transnasal Nicotine in Parkinson Disease |
Date of first enrolment:
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March 4, 2019 |
Target sample size:
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6 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03865121 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Mayela RodrÃguez Violante, MSc. |
Address:
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Telephone:
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Email:
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Affiliation:
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El Instituto Nacional de Neurologia Manuel Velasco Suarez |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY)
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Primary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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