Study of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease

NCT ID: NCT00115427

Last Updated: 2008-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Brief Summary

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This randomized study was designed to evaluate the efficacy and safety of IPu-infused liatermin (15mg/putamen/day) compared with placebo in subjects with symptomatic, levodopa-response Parkinson's disease. This study consisted of a 90-day evaluation period followed by implantation of the IPu delivery system and then a 6-month double-blind treatment period.

Detailed Description

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Conditions

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Idiopathic Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Liatermin (r-metHuGDNF)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Diagnosis of bilateral, idiopathic Parkinson's disease
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

http://download.veritasmedicine.com/REGFILES/amgen/20020168.pdf

To access clinical trial results information click on this link

Other Identifiers

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20020168

Identifier Type: -

Identifier Source: org_study_id

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