STEPS Trial - Spheramine Safety and Efficacy Study

Phase 2

Terminated

• Conditions: Parkinson Disease
• Interventions: Procedure: Placebo; Biological: Spheramine (BAY86-5280)

• Registration Number: NCT00206687
• Lead Sponsor: Bayer

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.

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 Timeline

• Study Start: 2003-01-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2012-05-14
• Study Completion: 2012-05-14
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Disposition First Posted: 2015-10-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Advanced Parkinson's disease for at least 5 years
• Good response to L-dopa
• Age 30 to 70 years
• Optimum oral therapy

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Exclusion Criteria

• Tremor only
• Dementia
• Very severe dyskinesia
• Previous brain surgery including deep brain stimulation
• Malignant disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo	-
Arm 1	Spheramine (BAY86-5280)	-

Primary Outcome Measures

Name	Time	Method
Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery	12 months post surgery

Secondary Outcome Measures

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