Parkinson Disease
Conditions
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.
Interventions
BIOLOGICALSpheramine (BAY86-5280)
Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells
PROCEDUREPlacebo
Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain.
Sponsors
Titan Pharmaceuticals
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery | 12 months post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Change in UPDRS Part III in ON at 12 months post surgery | 12 months post surgery |
| Amount of L-dopa reduction at 12 months post surgery | 12 months post surgery |
| Change in total UPDRS in ON and OFF at 12 months post surgery | 12 months post surgery |
| Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery | 12 months post surgery |
| Percent time spent in ON and OFF at 12 months post surgery | 12 months post surgery |
| Activities of Daily Living subscore of the UPDRS at 12 months post surgery | 12 months post surgery |
Countries
Germany, Spain, United States
Outcome results
None listed