NCT00206687

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_2 parkinson-disease

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_2 parkinson-disease

Geographic Reach
3 countries

15 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2012

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

9.4 years

First QC Date

September 13, 2005

Last Update Submit

October 29, 2024

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Change in UPDRS part III (Motor Score) in the defined medication at 12 months post surgery

    12 months post surgery

Secondary Outcomes (6)

  • Change in total UPDRS in ON and OFF at 12 months post surgery

    12 months post surgery

  • Change in UPDRS Part III in ON at 12 months post surgery

    12 months post surgery

  • Amount of L-dopa reduction at 12 months post surgery

    12 months post surgery

  • Activities of Daily Living subscore of the UPDRS at 12 months post surgery

    12 months post surgery

  • Quality of Life as assessed by PDQ-39, SF-36 and EQ-5D at 12 months post surgery

    12 months post surgery

  • +1 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL
Biological: Spheramine (BAY86-5280)

Arm 2

SHAM COMPARATOR
Procedure: Placebo

Interventions

Spheramine (BAY86-5280)BIOLOGICAL

Bilateral implantation of Spheramine into the postcommissural putamen, each side at a dose of 325,000 cells

Arm 1
PlaceboPROCEDURE

Sham surgery procedure without penetration of the dura mater. Nothing wil be implanted into the brain.

Arm 2

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced Parkinson's disease for at least 5 years
  • Good response to L-dopa
  • Age 30 to 70 years
  • Optimum oral therapy

You may not qualify if:

  • Tremor only
  • Dementia
  • Very severe dyskinesia
  • Previous brain surgery including deep brain stimulation
  • Malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Birmingham, Alabama, 35233, United States

Location

Unknown Facility

Los Angeles, California, 90095, United States

Location

Unknown Facility

Tampa, Florida, 33606, United States

Location

Unknown Facility

Atlanta, Georgia, 30329, United States

Location

Unknown Facility

Chicago, Illinois, 60612, United States

Location

Unknown Facility

Kansas City, Kansas, 66160, United States

Location

Unknown Facility

Boston, Massachusetts, 02118, United States

Location

Unknown Facility

New York, New York, 10029-6574, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19107, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Marburg, Hesse, 35039, Germany

Location

Unknown Facility

Homburg, Saarland, 66424, Germany

Location

Unknown Facility

Dresden, Saxony, 01307, Germany

Location

Unknown Facility

Hamburg, 22307, Germany

Location

Unknown Facility

Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 21565557DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 8, 2003

Primary Completion

May 14, 2012

Study Completion

May 14, 2012

Last Updated

October 31, 2024

Record last verified: 2024-10

Locations

ES(1)US(10)DE(4)