- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226460
Phase 2, Double-blind, Randomized, Controlled Multi-center Clinical Trial of the Safety and Efficacy of Transplanted Fetal Porcine Cells in Patients With Parkinson's Disease.
March 17, 2015 updated by: Genzyme, a Sanofi Company
The purpose of this study was to evaluate the differences in safety and efficacy between Parkinson's disease patients who either received transplantation of fetal porcine cells or placebo treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33606
- PD and Movement Disorders, University of South Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patient has idiopathic Parkinson's disease. a) with bradykinesia and either rest tremor or rigidity, b) history of asymmetry of Parkinson's disease signs, c) history of progression of Parkinson's disease signs, d) no other suspected cause of Parkinson's disease, e) the patient is L-DOPA responsive (based on the Treating Investigator's clinical judgment, the patient demonstrates a predictable ON response after the first daily dose of L-DOPA)
- The patient has had Parkinson's disease for at least 5 years (from onset of symptoms).
- The patient demonstrates unequivocal Clinical Off periods.
- Patient has been on a stable regimen of L-DOPA and any other anti-Parkinsonian medications for at least one month prior to start of screening.
- The patient demonstrates L-DOPA-or dopamine agonist-induced dyskinesias.
- The patient's age is 40-70.
- The patient is currently under "optimal medical therapy", as determined by the Treating Investigator.
- The patient has had a UPDRS assessment as per a modified CAPIT protocol at screening and the total UPDRS score in the defined OFF state was at least 60.
- If the patient is a woman of child bearing potential, she must not be nursing and an adequate form of birth control must be used for the duration of this trial.
- The patient has a normal chest x-ray and does not exhibit any signs or symptoms of coronary artery disease (on exam or on EKG) dysrhythmia (in order for surgery to be safely performed).
- The patient is able to understand and is willing to comply with study requirements; this may include travel within or outside the United States for neuroimaging testing and surgery. It will be necessary for a companion to travel with the patient.
- The patient is able to provide written informed consent.
- The patient understands that the Sponsor recommends that all patients in this trial avoid pregnancy and minimize the sharing of secretions with sexual partners.
- The patient is willing to participate in the life-long xenotransplantation registry.
Exclusion Criteria:
- The patient has a likely alternative diagnosis for Parkinsonism based on history, physical examination or laboratory testing. Atypical Parkinsonian variants (such as Shy-Drager, olivopontocerebellar atrophy, progressive supranuclear palsy and striatonigral degeneration) and secondary Parkinsonism (e.g., secondary to trauma or metabolic abnormalities; history of encephalitis, oculogyric crises or use of dopaminergic antagonists/depleting drugs) will be excluded.
- The patient has had a prior cranial neurosurgical procedure.
- The patient has MRI or CT evidence of abnormalities which could lead to Parkinsonism or make the patient an unsuitable neurosurgical candidate.
- The patient has a history of intracranial pathology (e.g., tumor, vascular malformation) that might make the patient an unsuitable neurosurgical candidate.
- The patient has a pre-existing medical condition that may interfere with the evaluation of the safety and/or effectiveness of the study agent or prevent study completion (e.g.:, symptomatic cardiac disease, impaired renal function or seizure disorder).
- The patient has a known sensitivity to products of porcine origin (e.g. pork).
- The patient has a known steroid or cyclosporine intolerance.
- The patient has significant cognitive impairment; specifically, a MMSE score of < 25, and, in the investigators judgment, the patient is demented.
- The patient has a Hamilton Depression score of > 16.
- The patient has hallucinations, delusions, psychosis or chronic psychiatric illness, with the exception of mild, L-DOPA induced hallucinations, or those caused by concomitant medications, which resolve with dose adjustment.
- The patient has a positive response to a tuberculin skin test (with the exception of patients who have either been inoculated for TB, or treated for the disease in the past).
- The patient has been treated during the 6 months prior to Screening with dopaminergic antagonists.
- (Females only) The patient is nursing or pregnant.
- The patient has taken tolcapone within 6 weeks of the Screening UPDRS exam.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
change in UPDRS
|
Secondary Outcome Measures
Outcome Measure |
---|
change in PET scan
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1997
Study Completion
January 1, 2001
Study Registration Dates
First Submitted
September 23, 2005
First Submitted That Met QC Criteria
September 23, 2005
First Posted (Estimate)
September 27, 2005
Study Record Updates
Last Update Posted (Estimate)
March 18, 2015
Last Update Submitted That Met QC Criteria
March 17, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PD96-1101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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