Clinical trial NCT00206687: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Titan Pharmaceuticals
First posted: 2005-09-21
Enrollment: 71
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery
timeFrame: 12 months post surgery
Secondary outcomes:
measure: Change in total UPDRS in ON and OFF at 12 months post surgery
timeFrame: 12 months post surgery
measure: Change in UPDRS Part III in ON at 12 months post surgery
timeFrame: 12 months post surgery
measure: Amount of L-dopa reduction at 12 months post surgery
timeFrame: 12 months post surgery
measure: Activities of Daily Living subscore of the UPDRS at 12 months post surgery
timeFrame: 12 months post surgery
measure: Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery
timeFrame: 12 months post surgery
measure: Percent time spent in ON and OFF at 12 months post surgery
timeFrame: 12 months post surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: New York
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Marburg
country: Germany
state: Hessen
city: Homburg
country: Germany
state: Saarland
city: Dresden
country: Germany
state: Sachsen
city: Hamburg
country: Germany
city: Barcelona
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.