Back to resultsSTEPS Trial - Spheramine Safety and Efficacy Study
Primary Purpose
Parkinson Disease
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Spheramine (BAY86-5280)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery
Secondary Outcome Measures
Change in total UPDRS in ON and OFF at 12 months post surgery
Change in UPDRS Part III in ON at 12 months post surgery
Amount of L-dopa reduction at 12 months post surgery
Activities of Daily Living subscore of the UPDRS at 12 months post surgery
Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery
Percent time spent in ON and OFF at 12 months post surgery
Full Information
NCT ID
NCT00206687
First Posted
September 13, 2005
Last Updated
September 23, 2015
Sponsor
Bayer
Collaborators
Titan Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00206687
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Study was completed, only life long extended follow-up phase was discontinued after 12 years.
Study Start Date
January 2003 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
Collaborators
Titan Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Sham Comparator
Intervention Type
Biological
Intervention Name(s)
Spheramine (BAY86-5280)
Intervention Description
Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain.
Primary Outcome Measure Information:
Title
Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery
Time Frame
12 months post surgery
Secondary Outcome Measure Information:
Title
Change in total UPDRS in ON and OFF at 12 months post surgery
Time Frame
12 months post surgery
Title
Change in UPDRS Part III in ON at 12 months post surgery
Time Frame
12 months post surgery
Title
Amount of L-dopa reduction at 12 months post surgery
Time Frame
12 months post surgery
Title
Activities of Daily Living subscore of the UPDRS at 12 months post surgery
Time Frame
12 months post surgery
Title
Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery
Time Frame
12 months post surgery
Title
Percent time spent in ON and OFF at 12 months post surgery
Time Frame
12 months post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35039
Country
Germany
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66424
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Hamburg
ZIP/Postal Code
22307
Country
Germany
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
21565557
Citation
Gross RE, Watts RL, Hauser RA, Bakay RA, Reichmann H, von Kummer R, Ondo WG, Reissig E, Eisner W, Steiner-Schulze H, Siedentop H, Fichte K, Hong W, Cornfeldt M, Beebe K, Sandbrink R; Spheramine Investigational Group. Intrastriatal transplantation of microcarrier-bound human retinal pigment epithelial cells versus sham surgery in patients with advanced Parkinson's disease: a double-blind, randomised, controlled trial. Lancet Neurol. 2011 Jun;10(6):509-19. doi: 10.1016/S1474-4422(11)70097-7. Epub 2011 May 10.
Results Reference
derived
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STEPS Trial - Spheramine Safety and Efficacy Study
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