STEPS Trial - Spheramine Safety and Efficacy Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 2, 2009

Start Date ^ICMJE

January 2003

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in UPDRS part III (Motor score) at 12 months

Change History

Complete list of historical versions of study NCT00206687 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in total UPDRS in ON and OFF at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ]
Change in UPDRS Part III in ON at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ]
Amount of L-dopa reduction at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ]
Activities of Daily Living subscore of the UPDRS at 12 months post surgery [ Time Frame: 12 month 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 month post surgery ] [ Designated as safety issue: No ]
Percent time spent in ON and OFF at 12 months post surgery [ Time Frame: 12 month post surgery ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

- 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

Descriptive Information

Brief Title ^ICMJE

STEPS Trial - Spheramine Safety and Efficacy Study

Official Title ^ICMJE

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

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Parkinson Disease

Intervention ^ICMJE

Procedure: Spheramine (BAY86-5280)
Procedure: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2012

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

30 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Germany, Spain

Administrative Information

NCT ID ^ICMJE

NCT00206687

Responsible Party

Therapeutic Area Head, Bayer Schering Pharma AG

Study ID Numbers ^ICMJE

91039, 305405

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Titan Pharmaceuticals

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

September 2009

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