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STEPS Trial - Spheramine Safety and Efficacy Study

NCT00206687 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-10-31

No results posted yet for this study

Summary

The purpose of the study is to explore the safety, tolerability and efficacy of Spheramine (cultured human retinal pigment epithelial cells on microcarriers) in Parkinson's Disease patients with advanced disease who have insufficient symptom control by optimum oral medication. Patients are randomized to receive Spheramine injections into both hemispheres or a sham surgical procedure in a ratio of 1:1. A three month pretreatment period must be completed prior to surgery. Time to endpoint is 24 months.

Conditions

  • Parkinson Disease

Interventions

BIOLOGICAL

Spheramine (BAY86-5280)

Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells

PROCEDURE

Placebo

Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain.

Sponsors & Collaborators

  • Titan Pharmaceuticals

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-08
Primary Completion
2012-05-14
Completion
2012-05-14

Countries

  • United States
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT00206687 on ClinicalTrials.gov