Study of Liatermin (r-metHuGDNF) Administered by Bilatera... | NCT00115427

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

NCT00115427

Sponsor

Amgen

Status

Completed

Last Update Posted

Jan 11, 2008Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Idiopathic Parkinson's Disease

Interventions

Liatermin (r-metHuGDNF)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 22, 2005

First Submission Date that Met QC Criteria

Jun 22, 2005

First Posted Date

Jun 23, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2008

Last Update Posted Date

Jan 11, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Liatermin (r-metHuGDNF)	Drug

Measure	Description	Time Frame
United Parkinson's Disease Rating Scale

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
MD	Amgen	Study Director

Label	URL
AmgenTrials clinical trials website	View source

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D051100	Glial Cell Line-Derived Neurotrophic Factor

Ancestor Terms

ID	Term
D051098	Glial Cell Line-Derived Neurotrophic Factors
D009414	Nerve Growth Factors
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Timed Motor Tests
Dyskinesia ratings
Diary ratings