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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: Clinical Trial Phase 2 study, sponsored by Bayer.
NCT00206687 is a Phase 2 study that was terminated before completion, run by Bayer. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00206687 stopped before completion
NCT00206687 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00206687 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00206687's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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