Parkinson DiseasePhase 2NCT00206687
STEPS Trial - Spheramine Safety and Efficacy Study
A Phase 2 study testing Spheramine (BAY86-5280) in people with Parkinson Disease, run by Bayer at 15 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Spheramine (BAY86-5280)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 8 Jan 2003to 14 May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced Parkinson's disease for at least 5 years
- Good response to L-dopa
- Age 30 to 70 years
- Optimum oral therapy
Who cannot join
- Tremor only
- Dementia
- Very severe dyskinesia
- Previous brain surgery including deep brain stimulation
- Malignant disease
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States10 sites
Study site
Atlanta, Georgia, 30329
Study site
Birmingham, Alabama, 35233
Study site
Boston, Massachusetts, 02118
Study site
Chicago, Illinois, 60612
Study site
Houston, Texas, 77030
Study site
Kansas City, Kansas, 66160
Study site
Los Angeles, California, 90095
Study site
New York, New York, 10029-6574
Study site
Philadelphia, Pennsylvania, 19107
Study site
Tampa, Florida, 33606
Germany4 sites
Study site
Dresden, Saxony, 01307
Study site
Hamburg, 22307
Study site
Homburg, Saarland, 66424
Study site
Marburg, Hesse, 35039
About this 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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Spheramine (BAY86-5280), Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spheramine (BAY86-5280)Biological
Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells
PlaceboProcedure or surgery
Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Biological: Spheramine (BAY86-5280) |
| Arm 2 | Sham comparator | Not described Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery
Measured: 12 months post surgery
Secondary outcomes (6)
Change in total UPDRS in ON and OFF at 12 months post surgery
Measured: 12 months post surgery
Change in UPDRS Part III in ON at 12 months post surgery
Measured: 12 months post surgery
Amount of L-dopa reduction at 12 months post surgery
Measured: 12 months post surgery
Activities of Daily Living subscore of the UPDRS at 12 months post surgery
Measured: 12 months post surgery
Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery
Measured: 12 months post surgery
Percent time spent in ON and OFF at 12 months post surgery
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study start8 Jan 2003
- Primary completion14 May 2012
- Study completion14 May 2012
Why it stopped: Study was completed, only life long extended follow-up phase was discontinued after 12 years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Titan Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206687
- Sponsor's protocol ID
- 91039
- Other IDs
- 305405
- Status last verified
- Oct 2024
- First submitted
- 13 Sep 2005
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21565557
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00206687
- Acronym / sponsor ID
- 91039
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was completed, only life long extended follow-up phase was discontinued after 12 years.
- Enrolment
- 71 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Titan Pharmaceuticals
- Study start
- 8 Jan 2003 (actual)
- Primary completion
- 14 May 2012 (actual)
- Study completion
- 14 May 2012 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: Spheramine (BAY86-5280) |
| Arm 2 | Sham comparator | Procedure: Placebo |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced Parkinson's disease for at least 5 years
- Good response to L-dopa
- Age 30 to 70 years
- Optimum oral therapy
Key exclusion criteria (5 listed)
- Tremor only
- Dementia
- Very severe dyskinesia
- Previous brain surgery including deep brain stimulation
- Malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spheramine (BAY86-5280)Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells | Biological | Arm 1 |
| PlaceboSham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain. | Procedure or surgery | Arm 2 |
Primary outcome
Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery
Time frame: 12 months post surgery
6 secondary outcomes
Change in total UPDRS in ON and OFF at 12 months post surgery
Time frame: 12 months post surgery
Change in UPDRS Part III in ON at 12 months post surgery
Time frame: 12 months post surgery
Amount of L-dopa reduction at 12 months post surgery
Time frame: 12 months post surgery
Activities of Daily Living subscore of the UPDRS at 12 months post surgery
Time frame: 12 months post surgery
Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery
Time frame: 12 months post surgery
Percent time spent in ON and OFF at 12 months post surgery
Time frame: 12 months post surgery
Results and safety
The study was stopped early (reason given: Study was completed, only life long extended follow-up phase was discontinued after 12 years.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Derived from this study: PubMed 21565557Gross 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spheramine (BAY86-5280) in people with Parkinson Disease, run by Bayer at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was completed, only life long extended follow-up phase was discontinued after 12 years.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery (time frame: 12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00206687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.