Your session is about to expire
← Back to Search
Other
L-DOPS for Parkinson's Disease
Phase 2
Waitlist Available
Led By Abraham Lieberman, MD
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Balance Score
Dynamic Stability
Falls
+2 moreSecondary outcome measures
Apathy
Freezing of Gait (FOG)
Orthostatic Hypotension
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: L-DOPSActive Control1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
Arizona State University, TempeUNKNOWN
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
63 Previous Clinical Trials
14,685 Total Patients Enrolled
Arizona State UniversityOTHER
283 Previous Clinical Trials
109,494 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger