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| Sponsor: | Neurim Pharmaceuticals Ltd. |
|---|---|
| Information provided by: | Neurim Pharmaceuticals Ltd. |
| ClinicalTrials.gov Identifier: | NCT00607451 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Levodopa-induced Dyskinesia |
Drug: Neu-120 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Neu-120
Capsules of 300, 900 and 2700mg; administered as a single dose with a one week washout between each administration.
|
| Experimental: 2 |
Drug: Neu-120
Capsules of 300, 900 and 2700mg; administered as a single dose with a one week washout between each administration.
|
| Experimental: 3 |
Drug: Neu-120
Capsules of 300, 900 and 2700mg; administered as a single dose with a one week washout between each administration.
|
| Experimental: 4 |
Drug: Neu-120
Capsules of 300, 900 and 2700mg; administered as a single dose with a one week washout between each administration.
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Tali NIR, Neurim Pharmaceuticals Ltd. |
| ClinicalTrials.gov Identifier: | NCT00607451 History of Changes |
| Other Study ID Numbers: | PoC_12001, POC_120-CTIL |
| Study First Received: | January 22, 2008 |
| Last Updated: | June 9, 2011 |
| Health Authority: | Israel: Ministry of Health |
|
Dyskinesias Parkinson Disease Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases |
Levodopa Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |