Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson Disease
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring L-dihydoxyphenylserine, L-DOPS, Northera
Eligibility Criteria
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.
Sites / Locations
- Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
L-DOPS
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. 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.
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.