STEPS Trial - Spheramine Safety and Efficacy Study

This study has been terminated.
(Study was completed, only life long extended follow-up phase was discontinued after 12 years.)
Sponsor:
Collaborator:
Titan Pharmaceuticals
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00206687
First received: September 13, 2005
Last updated: May 30, 2013
Last verified: May 2013
  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
Biological: Spheramine (BAY86-5280)
Procedure: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 months 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 months post surgery ] [ Designated as safety issue: No ]
  • Change in UPDRS Part III in ON at 12 months post surgery [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]
  • Amount of L-dopa reduction at 12 months post surgery [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]
  • Activities of Daily Living subscore of the UPDRS at 12 months post surgery [ Time Frame: 12 months 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 months post surgery ] [ Designated as safety issue: No ]
  • Percent time spent in ON and OFF at 12 months post surgery [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: January 2003
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: September 13, 2005
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on August 01, 2014