NCT00206687 is a Phase 2 clinical trial of Spheramine (BAY86-5280) in Parkinson Disease, sponsored by Bayer.

Who is sponsoring NCT00206687?

NCT00206687 is sponsored by Bayer.

What drugs are being tested in NCT00206687?

Interventions in NCT00206687: Spheramine (BAY86-5280), Placebo.

What condition does NCT00206687 study?

NCT00206687 studies Parkinson Disease.

Is NCT00206687 still recruiting?

NCT00206687 is currently terminated. Last updated 31 October 2024.

Last reviewed 2024-10-31 · How we verify

NCT00206687

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

STEPS Trial - Spheramine Safety and Efficacy Study

Terminated Phase 2 Last updated 31 October 2024

What this trial tests

Phase 2 trial testing Spheramine (BAY86-5280) in Parkinson Disease in 71 participants. Terminated before completion.

Timeline

8 January 2003

Primary endpoint
14 May 2012

14 May 2012

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	71
Start date	8 January 2003
Primary completion	14 May 2012
Estimated completion	14 May 2012
Sites	15 locations across United States, Germany, Spain

Drugs / interventions tested

Spheramine (BAY86-5280) — full drug profile →
Placebo

Conditions studied

Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Bayer — full company profile →

Who can join

Adults 30 to 70, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

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.
Gross RE, Watts RL, Hauser RA, Bakay RA, et al · · 2011 · cited 110× · PMID 21565557 · DOI 10.1016/s1474-4422(11)70097-7
Current Therapies in Clinical Trials of Parkinson's Disease: A 2021 Update.
Prasad EM, Hung SY. · · 2021 · cited 66× · PMID 34451813 · DOI 10.3390/ph14080717
Is the Immunological Response a Bottleneck for Cell Therapy in Neurodegenerative Diseases?
Salado-Manzano C, Perpiña U, Straccia M, Molina-Ruiz FJ, et al · · 2020 · cited 25× · PMID 32848630 · DOI 10.3389/fncel.2020.00250

Verify or expand the search:

Other trials of Spheramine (BAY86-5280)

Trials testing the same drug.

NCT00761436 — Pilot Study of Safety and Efficacy of Spheramine · Phase 2 · terminated

Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

NCT07399496 — Accelerated TMS for Apathy in PD · NA · recruiting
NCT07371338 — Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients · Phase 1 · recruiting
NCT07442370 — The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients · NA · recruiting
NCT06848205 — Percept Transitions in FOG and PD · NA · recruiting
NCT07432958 — A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (P · Phase 2 · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00206687 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 31 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00206687.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing