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STEPS Trial - Spheramine Safety and Efficacy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00206687
Recruitment Status : Terminated (Study was completed, only life long extended follow-up phase was discontinued after 12 years.)
First Posted : September 21, 2005
Last Update Posted : October 9, 2015
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Biological: Spheramine (BAY86-5280) Procedure: Placebo Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's Disease
Study Start Date : January 2003
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery [ Time Frame: 12 months post surgery ]

Secondary Outcome Measures :
  1. Change in total UPDRS in ON and OFF at 12 months post surgery [ Time Frame: 12 months post surgery ]
  2. Change in UPDRS Part III in ON at 12 months post surgery [ Time Frame: 12 months post surgery ]
  3. Amount of L-dopa reduction at 12 months post surgery [ Time Frame: 12 months post surgery ]
  4. Activities of Daily Living subscore of the UPDRS at 12 months post surgery [ Time Frame: 12 months post surgery ]
  5. Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery [ Time Frame: 12 months post surgery ]
  6. Percent time spent in ON and OFF at 12 months post surgery [ Time Frame: 12 months post surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206687


Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, California
Los Angeles, California, United States, 90095
United States, Florida
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30329
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
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
Marburg, Hessen, Germany, 35039
Homburg, Saarland, Germany, 66424
Dresden, Sachsen, Germany, 01307
Hamburg, Germany, 22307
Spain
Barcelona, Spain, 08036
Sponsors and Collaborators
Bayer
Titan Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00206687     History of Changes
Obsolete Identifiers: NCT00059007, NCT00185406
Other Study ID Numbers: 91039
305405 ( Other Identifier: Company Internal )
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: November 2014

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases