Trial Condition(s):
Parkinson Disease
STEPS Trial - Spheramine safety and efficacy study
Bayer Identifier:
91039
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Baylor College Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus Barmbek Hamburg, Germany, 22307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California, Los Angeles Los Angeles, United States, 90095 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Alabama at Birmingham Birmingham, United States, 35233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Boston University School of Medicine Boston, United States, 02118 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Sinai Medical Center New York, United States, 10029-6574 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Pennsylvania Philadelphia, United States, 19107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinik Gießen und Marburg GmbH Marburg, Germany, 35039 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rush University Medical Center Chicago, United States, 60612 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Emory University School of Medicine Atlanta, United States, 30329 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätskliniken des Saarlandes Homburg, Germany, 66424 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Univ.of South Florida College of Medicine Tampa, United States, 33606 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Kansas Medical Center Kansas City, United States, 66160 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Study of the safety, tolerability and efficacy of Spheramine implanted bilaterally into the postcommissural putamen of patients with advanced Parkinson's Disease
Trial Type:
Interventional
Intervention Type:
Biological/Vaccine
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgeryTimeframe: 12 months post surgery
Secondary Outcome
- Change in total UPDRS in ON and OFF at 12 months post surgeryTimeframe: 12 months post surgery
- Change in UPDRS Part III in ON at 12 months post surgeryTimeframe: 12 months post surgery
- Amount of L-dopa reduction at 12 months post surgeryTimeframe: 12 months post surgery
- Activities of Daily Living subscore of the UPDRS at 12 months post surgeryTimeframe: 12 months post surgery
- Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgeryTimeframe: 12 months post surgery
- Percent time spent in ON and OFF at 12 months post surgeryTimeframe: 12 months post surgery
Additional Information
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