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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02064166 |
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Date of registration:
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13/02/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.
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Scientific title:
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A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System Atrophy |
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Date of first enrolment:
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February 2014 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02064166 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Peter Novak', MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Former Associate Professor |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Males or females older than 17 years.
2. Clinical diagnosis of Parkinson disease or multiple system atrophy.
3. Provide written informed consent to participate in the study.
4. Understand that they may withdraw their consent at any time.
Exclusion Criteria:
1. Women who are pregnant or lactating.
2. In the investigator's opinion, have significant systemic, hepatic, cardiovascular,
renal or other illness that can interfere based on investigator judgment with the
trial.
3. History of dementia.
4. Unable to walk without help for at least 1 minute.
5. History of allergic reaction to insulin.
6. The presence of inflammation of nasal cavity that may prevents absorption of insulin.
Age minimum:
18 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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Multiple System Atrophy
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Intervention(s)
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Drug: Intranasal Insulin
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Primary Outcome(s)
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Change in Verbal Fluency FAS (F, A or S Words) Total Score
[Time Frame: Baseline and post-treatment]
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Secondary Outcome(s)
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Beck Depression Inventory Score (BDI)
[Time Frame: Baseline and post-treatment]
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Cognitive Impairment Using Montreal Cognitive Assessment (MoCA)
[Time Frame: Baseline and post-treatment]
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Modified Hoehn and Yahr Scale
[Time Frame: Baseline and post-treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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