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GDNF in ideopathicParkinsons Disease

NCT03652363 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-08-29

No results posted yet for this study

Summary

A Placebo Controlled Randomised Trial of GDNF vs placebo

The study will require patients to undergo surgery to implant microcatheters precisely into the brain. Patients will then attend clinic on a 2 weekly basis for infusions of a nerve growth factor called GDNF or placebo. Specific tests will also be carried out at regular intervals to assess your symptoms. All participants will undergo radio-isotope brain imaging at the beginning and end of the study. Periodically patients will also be required to undergo an MRI scan to assess the delivery of the study drug or placebo.

Conditions

  • Idiopathic Parkinson Disease

Interventions

DRUG

glial cell line-derived neurotrophic factor

Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via Convection Enhanced Delivery

Sponsors & Collaborators

  • North Bristol NHS Trust

    lead OTHER

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
2012-10-25
Primary Completion
2015-03-13
Completion
2016-04-01

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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 NCT03652363 on ClinicalTrials.gov