Expired Study
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Boston, Massachusetts 02118


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.


Study summary:

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.


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


Study is Available At:


Original ID:

91039


NCT ID:

NCT00206687


Secondary ID:

305405


Study Acronym:


Brief Title:

STEPS Trial - Spheramine Safety and Efficacy Study


Official Title:

Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's Disease


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

30 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bayer


Oversight Authority:

  • United States: Food and Drug Administration
  • Germany: Federal Institute for Drugs and Medical Devices


Reasons Why Stopped:

Study was completed, only life long extended


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

71


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bayer Study Director
Study Director
Bayer

Study Dates

Start Date:January 2003
Completion Date:May 2012
Completion Type:Actual
Primary Completion Date:May 2012
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 30, 2013
First Received Date:September 13, 2005

Study Outcomes

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

Study Interventions

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

Study Arms

Study Arm Type:Experimental
Arm Name:Arm 1
Study Arm Type:Sham Comparator
Arm Name:Arm 2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bayer
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Titan Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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