A Phase 1, Multicentre, Randomised, Double-blind Study to Assess Safety and Tolerability of Repeated Intracerebroventricular Administration of sNN0031 Infusion Solution to Patients With Parkinson's Disease

Newron Sweden AB5 sites in 3 countries1 target enrollmentJanuary 2015

ConditionsParkinson's Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Parkinson's Disease
Sponsor: Newron Sweden AB
Enrollment: 1
Locations: 5
Primary Endpoint: Tolerability of sNN0031 [Number of Adverse Events (AE) and Serious Adverse Events (SAE) occurring in each group over the study duration]
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase I, randomised, placebo-controlled study to assess the safety and tolerability of two 2-weeks cycles of i.c.v. administration of sNN0031 infusion solution to patients with PD of moderate severity with persisting on-off symptoms in spite of other PD medications.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

October 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Newron Sweden AB

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Disease duration ≥ 5 years (diagnosis based on medical history and neurological examination).
•Male or female, age 30 - 75 years inclusive.
•Motor fluctuations, with OFF-time \>1.5 hours during the day
•A Hoehn and Yahr stage of 2 to 4 during OFF phase
•Score \>22 on the UPDRS part III during ON phase
•Patients should be L-dopa responsive and demonstrate at least a 30% decrease in the UPDRS part III score after administration of L-dopa (L-dopa challenge test)
•Optimised and stable anti-Parkinson treatment for at least 3 months before screening

Exclusion Criteria

•The patient has any indication of forms of parkinsonism other than idiopathic Parkinson's disease
•The patient is in a late stage of Parkinson's disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms
•Patients who are on treatment with Duodopa or Apomorphine pump at the time of screening
•The patient has an implanted shunt for the drainage of CSF or an implanted Central Nervous System (CNS) catheter, or have received neurosurgical intervention related to PD (e.g. deep brain stimulation, thalamotomy etc.) or is scheduled to do so during the trial period
•Concurrent diagnoses of dementia with a score of 24 or lower on Mini-Mental State Examination (MMSE).
•The patient is depressed, as indicated by a Hamilton Depression Rating Scale (GRID-HAMD, 17-item scale) score \> 17
•Patients who are at high risk of suicide as judged by the rating of the Columbia Symptoms Suicide Rating Scale (C-SSRS)
•Patients with a history of increased intracranial pressure
•Ophthalmologic examination (funduscopy and visual acuity by Early Treatment of Diabetic Retinopathy Study (EDTRS) and perimetry) with clinically significant findings that imply safety concerns for this study
•The patient has a current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease

Outcomes

Primary Outcomes

Tolerability of sNN0031 [Number of Adverse Events (AE) and Serious Adverse Events (SAE) occurring in each group over the study duration]

Time Frame: 10 months

Number of AEs and SAEs occurring in each group over the study duration

Secondary Outcomes

Peak concentrations of sNN0031 in cerebrospinal fluid during two 14 day continuous infusion cycles(14 days x 2)
Pump flow error rate(10 months)
Number of patients with AEs related to the Implanted Infusion System(10 months)