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

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 Procedure: Placebo	Phase II

Genetics Home Reference related topics:

Parkinson disease

MedlinePlus related topics:

Parkinson's Disease

ChemIDplus related topics:

Spheramine

U.S. FDA Resources

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

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 ]

Enrollment:	68
Study Start Date:	January 2003
Estimated Study Completion Date:	June 2012

Arms	Assigned Interventions
Arm 1: Experimental	Procedure: Spheramine 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, 35233-6830

United States, California

	Los Angeles, California, United States, 90095-1721

United States, Florida

	Tampa, Florida, United States, 33606

United States, Georgia

	Atlanta, Georgia, United States, 30322

United States, Illinois

	Chicago, Illinois, United States, 60612-3833

United States, Kansas

	Kansas City, Kansas, United States, 66160

United States, Massachusetts

	Boston, Massachusetts, United States, 02118

United States, New York

	New York, New York, United States, 10029-6574

United States, Pennsylvania

	Philadelphia, Pennsylvania, United States, 19107

United States, Texas

	Houston, Texas, United States, 77030

Germany, Hamburg / 287

	Hamburg, Hamburg / 287, Germany, 22307

Germany, Hessen / 307

	Marburg, Hessen / 307, Germany, 35043

Germany, Saarland / 305

	Homburg, Saarland / 305, Germany, 66421

Germany, Sachsen / 313

	Dresden, Sachsen / 313, Germany, 01307

Spain

	Barcelona, Spain, 08036

Sponsors and Collaborators

Bayer

Titan Pharmaceuticals

Investigators


Study Director:	Bayer Study Director	Bayer

More 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

Responsible Party:	( Bayer Schering Pharma AG, Therapeutic Area Head )
Study ID Numbers:	91039, 305405
First Received:	September 13, 2005
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00206687
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:

Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008

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