Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson Disease

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

This research study is being done to determine whether treatment with L- Dihydroxyphenylserine (L-DOPS) versus placebo (an inactive substance that looks like study drug) in addition to other Parkinson Disease (PD) drugs will improve balance, walking, and reduce risk of falls and/or severity of falls in PD subjects. The study is also being done to determine the effectiveness, safety, and tolerability of L-DOPS, and whether it will decrease Freezing of Gait (FOG), improve apathy (generalized disinterest) or show a relationship between apathy and slowed movement and fall risk.

Key facts

Study ID

NCT02812147

Run by

St. Joseph's Hospital and Medical Center, Phoenix

People needed

20

Starts

2016-05-01

Expected to finish

2019-06-01

Last updated by the study team

2019-02-15

Who can join

Age: 30 and older, up to 83. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Barrow Neurological Institute/St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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