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NCT00206687 · ClinicalTrials.gov registry record · Phase 2
STEPS Trial - Spheramine Safety and Efficacy Study
A Phase 2 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT00206687 is a Phase 2 study that was terminated before completion, run by Bayer. The registered enrollment target is 71 participants.
The verdict
NCT00206687, a Phase 2 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Placebo
- BIOLOGICAL Spheramine (BAY86-5280)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2003-01-08 |
| Est. Completion | 2012-05-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00206687
The ClinicalTrials.gov registry entry for NCT00206687 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00206687 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00206687 about?
NCT00206687 is a clinical study titled "STEPS Trial - Spheramine Safety and Efficacy Study". 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 randomize...
What is the current status of trial NCT00206687?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2003-01-08. Estimated completion is 2012-05-14.
What interventions are being tested in trial NCT00206687?
The interventions under investigation include: Placebo (PROCEDURE), Spheramine (BAY86-5280) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00206687?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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