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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: |
NCT02812147 |
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Date of registration:
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25/05/2016 |
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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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Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson Disease
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Scientific title:
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Effect of L-Dihydoxyphenylserine (L-DOPS, Northera) a Central and Peripheral Norepinephrine Agent on Locomotion, Postural Stability (Balance), and Fall Risk Reduction in Parkinson Disease (PD) |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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20 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02812147 |
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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: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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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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Abraham Lieberman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Barrow Neurological Institute/St. Joseph's Hospital and Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject has voluntarily signed and dated an informed consent form (ICF) prior to any
participation in the study.
- Hoehn and Yahr Stage II, III, IV in an "on" state.
- Fell more than twice in past year.
- Montreal Cognitive Assessment (MOCA) score = 24.
- Stable dose of levodopa, dopamine agonist, amantadine, and/or monoamine oxidase B
inhibitor, i.e. unchanged for 3 months.
- Subject is ambulatory and able to walk = 10 meters with/without the use of an
assistive device.
Exclusion Criteria:
- Patients with atypical Parkinson disorders that result in a high number of falls.These
disorders include: Progressive Supranuclear Palsy (PSP), Multiple System Atrophy
(MSA), Primary Freezing of Gait (PFG), and Corticobasal Degeneration.
- Patients with dementia MOCA = 23.
- Patients with symptomatic Orthostatic Hypotension being treated with midodrine,
fludrocortisone or L-DOPS.
- Patients with uncontrolled hypertension.
- Patients with known allergies to L-DOPS or its excipients.
- Patients with major orthopedic problems of their hips or knees, and patients who need
hip or knee replacements.
- Patient with schizophrenia, a schizo-affective disorder, or a bipolar disorder.
- Patients with hallucinations, psychoses, or delusions.
- Patients with a history of recent stroke or myocardial infarction.
Age minimum:
30 Years
Age maximum:
83 Years
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: L-DOPS
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Drug: Placebo
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Primary Outcome(s)
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Balance Score
[Time Frame: 4 months]
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Falls
[Time Frame: 4 months]
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Postural Stability
[Time Frame: 4 months]
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Dynamic Stability
[Time Frame: 4 months]
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Motor Score
[Time Frame: 4 months]
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Secondary Outcome(s)
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Orthostatic Hypotension
[Time Frame: 4 months]
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Freezing of Gait (FOG)
[Time Frame: 4 months]
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Apathy
[Time Frame: 4 months]
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Secondary ID(s)
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PHX15BN108
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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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