STEPS Trial - Spheramine Safety and Efficacy Study

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00206687
• Other study ID #: 91039
• Secondary ID: 305405
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 23, 2015
• Start date: January 2003
• Est. completion date: May 2012

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00059007
• NCT00185406

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Titan Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery		12 months post surgery	No
Secondary	Change in total UPDRS in ON and OFF at 12 months post surgery		12 months post surgery	No
Secondary	Change in UPDRS Part III in ON at 12 months post surgery		12 months post surgery	No
Secondary	Amount of L-dopa reduction at 12 months post surgery		12 months post surgery	No
Secondary	Activities of Daily Living subscore of the UPDRS at 12 months post surgery		12 months post surgery	No
Secondary	Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery		12 months post surgery	No
Secondary	Percent time spent in ON and OFF at 12 months post surgery		12 months post surgery	No

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