stop_circleTerminated/Withdrawn
Parkinson Disease
Bayer Identifier:
91039
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
STEPS Trial - Spheramine safety and efficacy study
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.
Key Participants Requirements
Sex
BothAge
30 - 70 YearsTrial summary
Enrollment Goal
71Trial Dates
January 2003 - May 2012Phase
Phase 2Could I Receive a placebo
YesProducts
Spheramine (BAY86-5280)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Medizinische Fakultät Carl Gustav Carus | Dresden, 01307, Germany |
Completed | Baylor College | Houston, 77030, United States |
Completed | Allgemeines Krankenhaus Barmbek | Hamburg, 22307, Germany |
Completed | University of California, Los Angeles | Los Angeles, 90095, United States |
Completed | University of Alabama at Birmingham | Birmingham, 35233, United States |
Completed | Boston University School of Medicine | Boston, 02118, United States |
Completed | Mount Sinai Medical Center | New York, 10029-6574, United States |
Completed | University of Pennsylvania | Philadelphia, 19107, United States |
Completed | Universitätsklinik Gießen und Marburg GmbH | Marburg, 35039, Germany |
Completed | Rush University Medical Center | Chicago, 60612, United States |
Completed | Emory University School of Medicine | Atlanta, 30329, United States |
Completed | Universitätskliniken des Saarlandes | Homburg, 66424, Germany |
Completed | Univ.of South Florida College of Medicine | Tampa, 33606, United States |
Completed | University of Kansas Medical Center | Kansas City, 66160, United States |
Primary Outcome
- Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgerydate_rangeTime Frame:12 months post surgeryenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Change in total UPDRS in ON and OFF at 12 months post surgerydate_rangeTime Frame:12 months post surgeryenhanced_encryptionnoSafety Issue:
- Change in UPDRS Part III in ON at 12 months post surgerydate_rangeTime Frame:12 months post surgeryenhanced_encryptionnoSafety Issue:
- Amount of L-dopa reduction at 12 months post surgerydate_rangeTime Frame:12 months post surgeryenhanced_encryptionnoSafety Issue:
- Activities of Daily Living subscore of the UPDRS at 12 months post surgerydate_rangeTime Frame:12 months post surgeryenhanced_encryptionnoSafety Issue:
- Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgerydate_rangeTime Frame:12 months post surgeryenhanced_encryptionnoSafety Issue:
- Percent time spent in ON and OFF at 12 months post surgerydate_rangeTime Frame:12 months post surgeryenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
Biological/VaccineTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2