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Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease

NCT00400634 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-11-10

Study results available
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Summary

The purpose of this double blind study is to determine whether CERE-120 (adeno-associated virus serotype 2 \[AAV2\]-neurturin \[NTN\]) is effective and safe in the treatment of patients with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic injections targeting the putaminal region of the brain. The design of this study involves approximately 34 patients receiving CERE-120 treatment via stereotactic surgery and approximately 17 patients receiving sham stereotactic surgery (no CERE-120 administered).

Conditions

  • Idiopathic Parkinson's Disease

Interventions

DRUG

CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN])

CERE-120 5.4 x 10\^11 vg

PROCEDURE

Sham Surgery

Bilateral partial thickness burr holes placed, no intraparenchymal injections

Sponsors & Collaborators

  • Ceregene

    collaborator INDUSTRY

  • Sangamo Therapeutics

    lead INDUSTRY

Principal Investigators

  • Joao Siffert, M.D. · Ceregene

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
2006-11-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

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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 NCT00400634 on ClinicalTrials.gov