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

September 13, 2005
May 30, 2013
January 2003
May 2012   (final data collection date for primary outcome measure)
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 ]
Change in UPDRS part III (Motor score) at 12 months
Complete list of historical versions of study NCT00206687 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - Change in total UPDRS in ON and OFF at 12 months
  • - Change in UPDRS Part III in ON at 12 months
  • - Percent time spent in “on” and “off” at 12 months
  • - Amount of L-dopa reduction at 12 months
  • - Activities of Daily Living subscore of the UPDRS at 12 months
  • - Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months
Not Provided
Not Provided
 
STEPS Trial - Spheramine Safety and Efficacy Study
Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's Disease

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson Disease
  • Biological: Spheramine (BAY86-5280)
    Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells
  • Procedure: Placebo
    Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain.
  • Experimental: Arm 1
    Intervention: Biological: Spheramine (BAY86-5280)
  • Sham Comparator: Arm 2
    Intervention: Procedure: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
71
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain,   Germany
 
NCT00206687
91039, 305405
Yes
Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
Bayer
Titan Pharmaceuticals
Study Director: Bayer Study Director Bayer
Bayer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP