Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT00607451
Status:
TERMINATED
Last Update Posted:
2018-03-29
First Post:
2008-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, PK and PD Study of Neu-120 in the Treatment of Levodopa-induced Dyskinesia
Sponsor:
Neurim Pharmaceuticals Ltd.
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| POC_120-CTIL | None | None | View |