Status:
TERMINATED
Safety, Tolerability, PK and PD Study of Neu-120 in the Treatment of Levodopa-induced Dyskinesia
Lead Sponsor:
Neurim Pharmaceuticals Ltd.
Conditions:
Levodopa-induced Dyskinesia
Eligibility:
All Genders
30-80 years
Phase:
PHASE1
PHASE2
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 dyskine...
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...
Eligibility Criteria
Inclusion
- Male and female patients aged 30-80 years old (both ages included).
- Use of adequate and effective birth control measures (not including the rhythm method) during the study period and up to 3 months after the end of study in men and women of child-bearing potential or within two years of menopause (these women will perform a urine pregnancy test at the screening visit)
- Idiopathic Parkinson Disease (UK PD Society Brain Bank Clinical Diagnosis Criteria) diagnosed for at least 3 years.
- Hoehn and Yahr "ON" time (good medication response) stage II-III.
- Treatment with levodopa at an optimized dose alone or with dopamine agonists, MAO-B inhibitors or COMT inhibitors that are stable for at least 4 weeks prior to visit 1
- Use of hypnotics, sedatives, beta-blockers, anxiolytics and antidepressant only if stable for at least 4 weeks prior to visit 1.
- A minimal baseline Levodopa induced dyskinesia score of 2 or more on question 32 (dyskinesias present during more than 25% of the waking day); a score of 2 or more on question 33 of UPDRS (severely disabling dyskinesias) Part IV (historical information).
- A minimal basal level of motor fluctuations of 25% or more cumulative hours of OFF time every day during waking hours on the UPDRS Part IV (a minimal score of 1 on question 39 of UPDRS, historical information).
- Patients have at least 33% motor improvement in response to their levodopa challenge dose based on UPDRS motor score (Part III) at visit 1.
- Patients experiencing peak-dose dyskinesia with a score of at least 2 on 2 or more (≥2) areas (a score of at least 4) on the modified AIMS scale in response to their levodopa challenge dose at visit 1.
- Patients must be in good general health as determined by medical history, physical examination, ECG, vital signs, serum biochemistry and haematology.
- Patients must have signed an informed consent form .
Exclusion
- Patient has Non-idiopathic Parkinson's disease (e.g drug-induced or other form of secondary or atypical Parkinsonism).
- Neuropsychiatric exclusions: dementia (Mini Mental State Exam \< 23, history or presence of psychosis (such as visual hallucinations while taking dopamine agonists), history of or current Axis I or Axis II mental disorders according to DSM-IV; severe depression (Hamilton scale \> 17).
- Any clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.
- History or presence of gastrointestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Pregnant or breast feeding women.
- Drug abuse or history of drug abuse (including alcohol), known drug addiction.
- Patients with severe postural hypotension (\> 20 % variability between standing and supine).
- The following medications are forbidden for at least one month prior to visit 1 and during the course of the study: NMDA receptor antagonists (amantadine, memantine, budipine, dextromethorphan), medication with central dopaminergic antagonist activity (neuroleptics), CNS stimulants and sodium valproate (may exacerbate dyskinesias).
- Hoehn and Yahr score V when OFF (wheelchair-bound).
- The patient is participating in another study or has been participating in a study within the last 2 months.
- History of epilepsy and seizures.
- Any history of significant drug allergy.
- A history of unilateral or bilateral intracranial surgical procedures for Parkinson's Disease or any cerebral neurosurgery (except if occurred before the age of 18).
- History of severe pathology likely to recur during or immediately after the study.
- An inability to satisfactorily discontinue any study-forbidden medication.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00607451
Start Date
March 1 2008
End Date
August 27 2016
Last Update
March 29 2018
Active Locations (1)
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1
Neurim Pharmaceuticals Ltd.
Tel Aviv, Israel, 69710