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

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Collaborator: Arizona State University, Tempe
• Treatments: Dopamine Agonists; Droxidopa

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.