Phase 2, Double-blind, Randomized, Controlled Multi-center Clinical Trial of the Safety and Effic… (NCT00226460) | Clinical Trial Compass
CompletedPhase 2
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.
United StatesStarted 1997-08
Plain-language summary
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.
Who can participate
Age range40 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…