Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
71 participants
INTERVENTIONAL
2003-01-08
2012-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1
Spheramine (BAY86-5280)
Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells
Arm 2
Placebo
Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain.
Interventions
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Spheramine (BAY86-5280)
Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells
Placebo
Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain.
Eligibility Criteria
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Inclusion Criteria
* Good response to L-dopa
* Age 30 to 70 years
* Optimum oral therapy
Exclusion Criteria
* Dementia
* Very severe dyskinesia
* Previous brain surgery including deep brain stimulation
* Malignant disease
30 Years
70 Years
ALL
No
Sponsors
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Titan Pharmaceuticals
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Boston, Massachusetts, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Marburg, Hesse, Germany
Homburg, Saarland, Germany
Dresden, Saxony, Germany
Hamburg, , Germany
Barcelona, , Spain
Countries
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References
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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.
Other Identifiers
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305405
Identifier Type: OTHER
Identifier Source: secondary_id
91039
Identifier Type: -
Identifier Source: org_study_id
NCT00059007
Identifier Type: -
Identifier Source: nct_alias
NCT00185406
Identifier Type: -
Identifier Source: nct_alias
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