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Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease

NCT03295786 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-01-13

No results posted yet for this study

Summary

This study evaluates the safety and tolerability of CDNF in patients with Parkinson's disease, when dosed directly into the brain using an implanted investigational drug delivery system (DDS). Safety and accuracy of the DDS is also being evaluated. One-third of the patients will receive monthly infusions with placebo and two-third of the patients will receive monthly infusions with either mid- or high-doses of CDNF for a period of 6 months.

Conditions

Interventions

DRUG

Cerebral Dopamine Neurotrophic Factor

Repeated intracerebral infusions

DEVICE

Renishaw Drug Delivery System

Stereotactically implanted device

Sponsors & Collaborators

  • Renishaw plc.

    collaborator UNKNOWN

  • Herantis Pharma Plc.

    lead INDUSTRY

Principal Investigators

  • Per Svenningsson, MD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2019-12-19
Completion
2019-12-19

Countries

  • Finland
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT03295786 on ClinicalTrials.gov