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Link to original content: http://pubmed.ncbi.nlm.nih.gov/16429411/
Randomized controlled trial of intraputamenal glial cell line-derived neurotrophic factor infusion in Parkinson disease - PubMed Skip to main page content
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Clinical Trial
. 2006 Mar;59(3):459-66.
doi: 10.1002/ana.20737.

Randomized controlled trial of intraputamenal glial cell line-derived neurotrophic factor infusion in Parkinson disease

Anthony E Lang  1 , Steven Gill, Nik K Patel, Andres Lozano, John G Nutt, Richard Penn, David J Brooks, Gary Hotton, Elena Moro, Peter Heywood, Matthew A Brodsky, Kim Burchiel, Patrick Kelly, Arif Dalvi, Burton Scott, Mark Stacy, Dennis Turner, V G Frederich Wooten, William J Elias, Edward R Laws, Vijay Dhawan, A Jon Stoessl, James Matcham, Robert J Coffey, Michael Traub
Affiliations
Clinical Trial

Randomized controlled trial of intraputamenal glial cell line-derived neurotrophic factor infusion in Parkinson disease

Anthony E Lang et al. Ann Neurol. 2006 Mar.

Erratum in

  • Ann Neurol. 2006 Dec;60(6):747

Abstract

Objective: Glial cell line-derived neurotrophic factor (GDNF) exerts potent trophic influence on midbrain dopaminergic neurons. This randomized controlled clinical trial was designed to confirm initial clinical benefits observed in a small, open-label trial using intraputamenal (Ipu) infusion of recombinant human GDNF (liatermin).

Methods: Thirty-four PD patients were randomized 1 to 1 to receive bilateral continuous Ipu infusion of liatermin 15 microg/putamen/day or placebo. The primary end point was the change in Unified Parkinson Disease Rating Scale (UPDRS) motor score in the practically defined off condition at 6 months. Secondary end points included other UPDRS scores, motor tests, dyskinesia ratings, patient diaries, and (18)F-dopa uptake.

Results: At 6 months, mean percentage changes in "off" UPDRS motor score were -10.0% and -4.5% in the liatermin and placebo groups, respectively. This treatment difference was not significant (95% confidence interval, -23.0 to 12.0, p = 0.53). Secondary end point results were similar between the groups. A 32.5% treatment difference favoring liatermin in mean (18)F-dopa influx constant (p = 0.019) was observed. Serious, device-related adverse events required surgical repositioning of catheters in two patients and removal of devices in another. Neutralizing antiliatermin antibodies were detected in three patients (one on-study and two in the open-label extension).

Interpretation: Liatermin did not confer the predetermined level of clinical benefit to patients with PD despite increased (18)F-dopa uptake. It is uncertain whether technical differences between this trial and positive open-label studies contributed in any way this negative outcome.

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