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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00038116 |
The purpose of this trial is to determine if patients who received embryonic dopamine cell implant surgery showed significantly greater improvement in their Parkinson's disease than a control group undergoing the placebo treatment, and to determine if the cell implant surgery was more effective in younger or older patients.
Condition | Intervention | Phase |
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Parkinson Disease |
Procedure: embryonic dopamine cell implant surgery Procedure: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment |
Enrollment: | 40 |
Study Start Date: | May 1995 |
Estimated Study Completion Date: | May 2008 |
Arms | Assigned Interventions |
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1: Active Comparator |
Procedure: embryonic dopamine cell implant surgery
Half of the participants received the cell implant surgery, while the other half received the placebo. After the double-blind phase of the study, patients in the placebo group had the option of receiving tissue implants. Fourteen of these patients eventually had transplants.
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2: Placebo Comparator |
Procedure: placebo
sham surgery
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Parkinson's disease is caused by the death of a small number of nerve cells that produce a critical chemical called dopamine. The drug L-dopa can partially make up for the lack of dopamine. As time goes on, however, most patients notice that the drugs do not work as well. Oftentimes, patients develop great fluctuations in motor control. Off drugs they cannot move, and on drugs they have excess, exaggerated movements. Research in animals over the last 20 years has shown that dopamine cells can be replaced by transplants of new cells obtained from fetal brain tissue. For the past 14 years, several laboratories around the world have been performing similar transplants of human fetal brain tissue on patients with Parkinson's disease. So far, it has been impossible to compare results from the different groups because no two centers are performing transplants in the same way.
This study seeks to get around that problem using a controlled clinical trial that compares the embryonic dopamine cell implant surgery with a placebo treatment. A total of 40 patients were recruited--half received the cell implant surgery, while the other half received the placebo. After the double-blind phase of the study, patients in the placebo group had the option of receiving tissue implants. Fourteen of these patients eventually had transplants. At present, this study is providing long-term follow-up evaluation and treatment for the subjects.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
United States, Colorado | |
University Hospital, the University of Colorado Health Sciences Center | |
Denver, Colorado, United States, 80262 | |
United States, New York | |
The Movement Disorder Center, Columbia-Presbyterian Hospital | |
New York, New York, United States, 10032 | |
North Shore University Hospital | |
Manhasset, New York, United States, 11030 |
Principal Investigator: | Curt R. Freed, M.D. | University of Colorado at Denver and Health Sciences Center |
Study ID Numbers: | R01NS32368 |
Study First Received: | May 29, 2002 |
Last Updated: | November 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00038116 History of Changes |
Health Authority: | United States: Federal Government |
Parkinson's disease PD dopamine embryonic dopamine cell implant surgery tissue implants |
Neurotransmitter Agents Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Cardiovascular Agents Brain Diseases Neurodegenerative Diseases |
Dopamine Parkinson Disease Movement Disorders Dopamine Agents Parkinsonian Disorders Peripheral Nervous System Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics Cardiotonic Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Cardiovascular Agents Brain Diseases Neurodegenerative Diseases |
Protective Agents Pharmacologic Actions Dopamine Autonomic Agents Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Parkinsonian Disorders |