Safety, Tolerability, PK and PD Study of Neu-120 in the Treatment of Levodopa-induced Dyskinesia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00607451
• Date of registration: 22/01/2008
• Prospective Registration: Yes
• Primary sponsor: Neurim Pharmaceuticals Ltd.
• Public title: Safety, Tolerability, PK and PD Study of Neu-120 in the Treatment of Levodopa-induced Dyskinesia
• Scientific 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
• Date of first enrolment: March 2008
• Target sample size: 8
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00607451
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

Israel

Contacts

• Name: Tali Nir
• Affiliation: Neurim Pharmaceutical Ltd.

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Levodopa-induced Dyskinesia

Intervention(s)

Drug: Neu-120

Primary Outcome(s)

Improving levodopa-induced dyskinesia [Time Frame: single day]

Secondary Outcome(s)

Safety and toleability [Time Frame: single dose]

Secondary ID(s)

POC_120-CTIL

PoC_12001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors