Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson Disease
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)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Arizona
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Phoenix, Arizona, United States, 85013
- Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: L-DOPS
All participants will be on levodopa/carbidopa, and may be on additional dopaminergic drugs including dopamine agonists and/or monoamine type B oxidase inhibitors or amantadine.
L-dihydoxyphenylserine will be added, administered as an oral capsule 3 times a day for 4 months.
Dosing will begin at 100 mg of L-DOPS three times per day and titrated upward, by 100 mg three times a day, as tolerated.
Tolerability will be evaluated based upon questionnaires, patient interviews, vital signs and investigator examination.
In order to participate in the study, all subjects must be able to tolerate a minimum tolerated dose of 400 mg three times per day (1200mg/day).
Subject maximum dose will be 600 mg three times per day (1800mg/day).
Patients will be maintained on this dose for 4 months (until the cross-over).
After a 7-day washout, participants will cross over to the Placebo arm.
|
Added as described in the Arm/Group Descriptions.
Other Names:
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Placebo Comparator: Placebo
All participants will be on levodopa/carbidopa, and may be on additional dopaminergic drugs including dopamine agonists and/or monoamine type B oxidase inhibitors or amantadine.
Placebo will be added, administered as an oral capsule 3 times a day for 4 months.
Dosing will begin at 100 mg of placebo three times per day and titrated upward, by 100 mg three times a day, as tolerated.
Tolerability will be evaluated based upon questionnaires, patient interviews, vital signs and investigator examination.
In order to participate in the study, all subjects must be able to tolerate a minimum tolerated dose of 400 mg three times per day (1200mg/day).
Subject maximum dose will be 600 mg three times per day (1800mg/day).
Patients will be maintained on this dose for 4 months (until the cross-over) After a 7-day washout, participants will cross over to the L-DOPS arm.
|
Added as described in the Arm/Group Descriptions.dded
as described in the Arm/Group Descriptions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor Score
Time Frame: 4 months
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Measured with United Parkinson's Disease Rating Scale (Part III 0-45) in the medication state of "on", "off", or both.
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4 months
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Balance Score
Time Frame: 4 months
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Measured using Barrow Neurologic Institute (BNI) Balance Scale 0-20, in the medication state of "on", "off", or both.
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4 months
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Postural Stability
Time Frame: 4 months
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Measured using a NeuroCom Equitest System, which tests sensory organization, motor control time, and postural sway measures, in the medication state of "on", "off", or both.
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4 months
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Dynamic Stability
Time Frame: 4 months
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Dynamic stability is measured by wearable devices (Inertial Measurement Units) that collect gait parameters during gait and postural transitions,in the medication state of "on", "off", or both.
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4 months
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Falls
Time Frame: 4 months
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Incidence of falls is self-report, in the medication state of "on", "off", or both.
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4 months
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Freezing of Gait (FOG)
Time Frame: 4 months
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Measured using United Parkinson's Disease Rating Scale (FOG subtests 2.13 and 3.11) 0-8, in the medication state of "on", "off", or both.
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4 months
|
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Apathy
Time Frame: 4 months
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Measured using Apathy in Parkinson's Disease Questionnaire 0-42, in the medication state of "on", "off", or both.
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4 months
|
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Orthostatic Hypotension
Time Frame: 4 months
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Measured using Orthostatic Hypotension Symptom Assessment 0-10,in the medication state of "on", "off", or both.
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4 months
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Abraham Lieberman, MD, Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- PHX15BN108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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