Levodopa-induced Dyskinesia Clinical Trial
Official title:
A Double-blind, Placebo Controlled, Crossover, Ascending Single Dose Safety Tolerability, Pharmacokinetic and Pharmacodynamic Study of Neu-120 in Patients With Advanced Phase Idiopathic Parkinson's Disease With Levodopa Induced Dyskinesia
The purpose of this study is to determine the safety, tolerability, pharmacokinetic and pharmacodynamic effects of single doses of Neu-120 in Parkinson's disease patients with levodopa-induced dyskinesia.
Parkinson's disease is a progressive neurological disorder characterized by tremor,
bradykinesia, rigidity, gait and postural instability and a variety of nonmotor symptoms.
While levodopa effectively alleviates all symptoms of Parkinson's disease and restores motor
function, within 3 to 5 years the majority of Parkinsonian patients develop levodopa-induced
side effects, mainly dyskinesias (involuntary and uncontrolled movements such as twisting of
a hand or a limb) and wearing off (progressive shortening of therapeutic response duration).
Dyskinesias are the most disabling side effects of long term levodopa therapy in Parkinsonian
patients. There is currently no approved drug for levodopa-induced dyskinesia.
The effects of three single ascending doses of orally administered Neu-120 will be evaluated
in a double blind placebo controlled crossover proof of concept study. Following a 1-day
screening visit, patients will be randomized to receive three single ascending doses of
Neu-120 and placebo.
Patients will be admitted to the clinic on the evening prior to each visit on five occasions,
each separated by 7 (-3) days. Levodopa challenges will be performed at baseline (visit 1)
and at each treatment visit after withdrawal of all antiparkinsonian medications for 12
hours.
Blood samples will be taken for measurement of Neu-120 and levodopa plasma levels.
Primary parameter is improvement in levodopa-induced dyskinesia. Secondary parameters are
safety, tolerability, pharmacodynamic assessments of dyskinesias and motor function,
Neu-120/levodopa pharmacokinetic profiles and correlation between pharmacodynamic effects and
Neu-120/levodopa levels.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04173845 -
Double Randomized and Placebo Controlled Trail of Tianqi Pingchan Granule to Prevent Levodopa-Induced Dyskinesia
|
N/A | |
| Completed |
NCT05435729 -
A Pharmacodynamics and Safety Study of DSP-9632P in Patients With Levodopa-Induced Dyskinesia in Parkinson's Disease
|
Phase 1 | |
| Active, not recruiting |
NCT06021756 -
Phase I Open-label Study of Low-dose Ketamine Infusion Treatment in Levodopa-Induced Dyskinesia in Parkinson's Disease
|
Phase 1 |