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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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8 January 2018 |
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Main ID: |
NCT02857244 |
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Date of registration:
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25/07/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients
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Scientific title:
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A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients |
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Date of first enrolment:
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November 2016 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02857244 |
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Study type:
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Interventional |
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Study design:
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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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United States
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Contacts
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Name:
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Tao Xie, 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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University of Chicago |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Parkinsonian patient with Parkinson's disease per UK brain bank criteria 15,
- or PSP per SPSP-NINDS criteria 16,
- FOG at off or on dopaminergic medication or both.
Exclusion Criteria:
- Patients with psychosis,
- unable to walk without assistance,
- seizures,
- or allergy to any of these three medications on trial.
Age minimum:
18 Years
Age maximum:
100 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Modafinil
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Drug: Donepezil
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Drug: Duloxetine
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Primary Outcome(s)
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Freezing of Gait
[Time Frame: From baseline to completion of drug regimen (4 weeks of duloxetine, 2 weeks of duloxetine & donepezil, 2 weeks & 3 days modafinil)]
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Secondary Outcome(s)
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Change in anxiety
[Time Frame: From baseline to completion of drug regiment (4 weeks of duloxetine, 2 weeks of duloxetine & donepezil, 2 weeks & 3 days modafinil)]
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Change in cognition
[Time Frame: From baseline to completion of drug regiment (4 weeks of duloxetine, 2 weeks of duloxetine & donepezil, 2 weeks & 3 days modafinil)]
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Change in sleep quality
[Time Frame: From baseline to completion of drug regiment (4 weeks of duloxetine, 2 weeks of duloxetine & donepezil, 2 weeks & 3 days modafinil)]
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Change in quality of life
[Time Frame: From baseline to completion of drug regiment (4 weeks of duloxetine, 2 weeks of duloxetine & donepezil, 2 weeks & 3 days modafinil)]
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Change in symptom score/severity
[Time Frame: From baseline to completion of drug regiment (4 weeks of duloxetine, 2 weeks of duloxetine & donepezil, 2 weeks & 3 days modafinil)]
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Secondary ID(s)
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IRB15-1577
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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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