Terminated/Withdrawn

Parkinson Disease

Bayer Identifier:

91039

ClinicalTrials.gov Identifier:

NCT00206687

EudraCT Number:

Not Available

EU CT Number:

Not Available

STEPS Trial - Spheramine safety and efficacy study

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.

Key Participants Requirements

Sex

Both

Age

30 - 70 Years

Trial summary

Enrollment Goal

Trial Dates

January 2003 - May 2012

Phase

Phase 2

Could I Receive a placebo

Yes

Products

Spheramine (BAY86-5280)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Hospital Clínic i Provincial de Barcelona	Barcelona, 08036, Spain
Completed	Medizinische Fakultät Carl Gustav Carus	Dresden, 01307, Germany
Completed	Baylor College	Houston, 77030, United States
Completed	Allgemeines Krankenhaus Barmbek	Hamburg, 22307, Germany
Completed	University of California, Los Angeles	Los Angeles, 90095, United States
Completed	University of Alabama at Birmingham	Birmingham, 35233, United States
Completed	Boston University School of Medicine	Boston, 02118, United States
Completed	Mount Sinai Medical Center	New York, 10029-6574, United States
Completed	University of Pennsylvania	Philadelphia, 19107, United States
Completed	Universitätsklinik Gießen und Marburg GmbH	Marburg, 35039, Germany
Completed	Rush University Medical Center	Chicago, 60612, United States
Completed	Emory University School of Medicine	Atlanta, 30329, United States
Completed	Universitätskliniken des Saarlandes	Homburg, 66424, Germany
Completed	Univ.of South Florida College of Medicine	Tampa, 33606, United States
Completed	University of Kansas Medical Center	Kansas City, 66160, United States

Primary Outcome

Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery
Time Frame:
12 months post surgery
Safety Issue:
no

Secondary Outcome

Change in total UPDRS in ON and OFF at 12 months post surgery
Time Frame:
12 months post surgery
Safety Issue:
no
Change in UPDRS Part III in ON at 12 months post surgery
Time Frame:
12 months post surgery
Safety Issue:
no
Amount of L-dopa reduction at 12 months post surgery
Time Frame:
12 months post surgery
Safety Issue:
no
Activities of Daily Living subscore of the UPDRS at 12 months post surgery
Time Frame:
12 months post surgery
Safety Issue:
no
Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery
Time Frame:
12 months post surgery
Safety Issue:
no
Percent time spent in ON and OFF at 12 months post surgery
Time Frame:
12 months post surgery
Safety Issue:
no

Trial design

Study of the safety, tolerability and efficacy of Spheramine implanted bilaterally into the postcommissural putamen of patients with advanced Parkinson's Disease

Trial Type

Interventional

Intervention Type

Biological/Vaccine

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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