STEPS Trial – Spheramine Safety and Efficacy Study

Overview

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.

Full Title of Study: “Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2012

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Arm 1
  • Sham Comparator: Arm 2

Clinical Trial Outcome Measures

Primary Measures

  • Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery
    • Time Frame: 12 months post surgery

Secondary Measures

  • Change in total UPDRS in ON and OFF at 12 months post surgery
    • Time Frame: 12 months post surgery
  • Change in UPDRS Part III in ON at 12 months post surgery
    • Time Frame: 12 months post surgery
  • Amount of L-dopa reduction at 12 months post surgery
    • Time Frame: 12 months post surgery
  • Activities of Daily Living subscore of the UPDRS at 12 months post surgery
    • Time Frame: 12 months post surgery
  • Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery
    • Time Frame: 12 months post surgery
  • Percent time spent in ON and OFF at 12 months post surgery
    • Time Frame: 12 months post surgery

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Collaborator
    • Titan Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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