NCT00115427

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2005

Completed
Last Updated

January 11, 2008

Status Verified

January 1, 2008

First QC Date

June 22, 2005

Last Update Submit

January 10, 2008

Conditions

Idiopathic Parkinson's Disease

Keywords

Bilateral, Idiopathic Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • United Parkinson's Disease Rating Scale

Secondary Outcomes (4)

  • Timed Motor Tests

  • Dyskinesia ratings

  • Diary ratings

  • Patient reported outcomes measures

Interventions

Liatermin (r-metHuGDNF)DRUG

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

Glial Cell Line-Derived Neurotrophic Factor

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Glial Cell Line-Derived Neurotrophic FactorsNerve Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsNerve Tissue ProteinsBiological Factors

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 22, 2005

First Posted

June 23, 2005

Study Start

March 1, 2003

Last Updated

January 11, 2008

Record last verified: 2008-01