Trial Condition(s):

Parkinson Disease

STEPS Trial - Spheramine safety and efficacy study

Bayer Identifier:

91039

ClinicalTrials.gov Identifier:

NCT00206687

EudraCT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

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.

Inclusion Criteria
- Advanced Parkinson's disease for at least 5 years
 - Good response to L-dopa
 - Age 30 to 70 years
 - Optimum oral therapy
Exclusion Criteria
- Tremor only
 - Dementia
 - Very severe dyskinesia
 - Previous brain surgery including deep brain stimulation
 - Malignant disease

Trial Summary

Enrollment Goal
71
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Spheramine (BAY86-5280)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Baylor College

Houston, United States, 77030

Status
Completed
 
Locations

Allgemeines Krankenhaus Barmbek

Hamburg, Germany, 22307

Status
Completed
 
Locations

University of California, Los Angeles

Los Angeles, United States, 90095

Status
Completed
 
Locations

University of Alabama at Birmingham

Birmingham, United States, 35233

Status
Completed
 
Locations

Boston University School of Medicine

Boston, United States, 02118

Status
Completed
 
Locations

Mount Sinai Medical Center

New York, United States, 10029-6574

Status
Completed
 
Locations

University of Pennsylvania

Philadelphia, United States, 19107

Status
Completed
 
Locations

Universitätsklinik Gießen und Marburg GmbH

Marburg, Germany, 35039

Status
Completed
 
Locations

Rush University Medical Center

Chicago, United States, 60612

Status
Completed
 
Locations

Emory University School of Medicine

Atlanta, United States, 30329

Status
Completed
 
Locations

Universitätskliniken des Saarlandes

Homburg, Germany, 66424

Status
Completed
 
Locations

Univ.of South Florida College of Medicine

Tampa, United States, 33606

Status
Completed
 
Locations

University of Kansas Medical Center

Kansas City, United States, 66160

Status
Completed
 

Trial Design