stop_circleTerminated/Withdrawn

Parkinson Disease

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

Both

Age

30 - 70 Years
  • - Advanced Parkinson's disease for at least 5 years
    - Good response to L-dopa
    - Age 30 to 70 years
    - Optimum oral therapy
  • - Tremor only
    - Dementia
    - Very severe dyskinesia
    - Previous brain surgery including deep brain stimulation
    - Malignant disease

Trial summary

Enrollment Goal
71
Trial Dates
January 2003 - May 2012
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Spheramine (BAY86-5280)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Baylor CollegeHouston, 77030, United States
Completed
Allgemeines Krankenhaus BarmbekHamburg, 22307, Germany
Completed
University of California, Los AngelesLos Angeles, 90095, United States
Completed
University of Alabama at BirminghamBirmingham, 35233, United States
Completed
Boston University School of MedicineBoston, 02118, United States
Completed
Mount Sinai Medical CenterNew York, 10029-6574, United States
Completed
University of PennsylvaniaPhiladelphia, 19107, United States
Completed
Universitätsklinik Gießen und Marburg GmbHMarburg, 35039, Germany
Completed
Rush University Medical CenterChicago, 60612, United States
Completed
Emory University School of MedicineAtlanta, 30329, United States
Completed
Universitätskliniken des SaarlandesHomburg, 66424, Germany
Completed
Univ.of South Florida College of MedicineTampa, 33606, United States
Completed
University of Kansas Medical CenterKansas City, 66160, United States

Primary Outcome

  • Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery
    date_rangeTime Frame:
    12 months post surgery
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Change in total UPDRS in ON and OFF at 12 months post surgery
    date_rangeTime Frame:
    12 months post surgery
    enhanced_encryption
    Safety Issue:
    no
  • Change in UPDRS Part III in ON at 12 months post surgery
    date_rangeTime Frame:
    12 months post surgery
    enhanced_encryption
    Safety Issue:
    no
  • Amount of L-dopa reduction at 12 months post surgery
    date_rangeTime Frame:
    12 months post surgery
    enhanced_encryption
    Safety Issue:
    no
  • Activities of Daily Living subscore of the UPDRS at 12 months post surgery
    date_rangeTime Frame:
    12 months post surgery
    enhanced_encryption
    Safety Issue:
    no
  • Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery
    date_rangeTime Frame:
    12 months post surgery
    enhanced_encryption
    Safety Issue:
    no
  • Percent time spent in ON and OFF at 12 months post surgery
    date_rangeTime Frame:
    12 months post surgery
    enhanced_encryption
    Safety Issue:
    no

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