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A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease

NCT00866502 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-01-12

No results posted yet for this study

Summary

This study is conducted to evaluate the safety and tolerability of the drug product sNN0031, containing Platelet Derived Growth Factor (PDGF), when administered directly into one of the fluid filled cavities in the brain using an implanted catheter and an implanted SynchroMed® II pump. Patients with a diagnosis of Parkinson's disease will be enrolled.

Conditions

Interventions

DRUG

sNN0031

Continuous ICV infusion for two weeks

DRUG

Placebo

Continous ICV infusion

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Newron Sweden AB

    lead INDUSTRY

Principal Investigators

  • Sven Pålhagen, MD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00866502 on ClinicalTrials.gov