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 range
40 Years – 70 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.