STEPS Trial - Spheramine Safety and Efficacy Study - Full Text View

Sponsors and Collaborators:	Bayer Titan Pharmaceuticals
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00206687

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.

Condition	Intervention	Phase
Parkinson Disease	Procedure: Spheramine (BAY86-5280) Procedure: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease Surgery

Drug Information available for: Spheramine

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	68
Study Start Date:	January 2003
Estimated Study Completion Date:	June 2012
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Procedure: Spheramine (BAY86-5280) Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells
Arm 2: Sham Comparator	Procedure: Placebo Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain.

Detailed Description:

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206687

Locations

United States, Alabama

Birmingham, Alabama, United States, 35294
United States, California

Los Angeles, California, United States, 90095
United States, Florida

Tampa, Florida, United States, 33606
United States, Georgia

Atlanta, Georgia, United States, 30322
United States, Illinois

Chicago, Illinois, United States, 60612
United States, Kansas

Kansas City, Kansas, United States, 66160
United States, Massachusetts

Boston, Massachusetts, United States, 02118-2394
United States, New York

New York, New York, United States, 10029
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19104
United States, Texas

Houston, Texas, United States, 77030
Germany

Hamburg, Germany, 22307
Germany, Hessen

Marburg, Hessen, Germany, 35043
Germany, Saarland

Homburg, Saarland, Germany, 66421
Germany, Sachsen

Dresden, Sachsen, Germany, 01307
Spain

Barcelona, Spain, 08036

Sponsors and Collaborators

Bayer

Titan Pharmaceuticals

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

This study is the same study protocol as NCT00185406, with different locations. This link exits the ClinicalTrials.gov site

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91039, 305405
Study First Received:	September 13, 2005
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00206687 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on September 11, 2009