Phase II Double Blind Controlled Trial of Nigral Grafting in Patients With Parkinson's Disease
NCT ID: NCT00004387
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
1996-01-31
Brief Summary
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I. Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's disease.
Detailed Description
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Group B patients receive 2 separate placebo operations without fetal transplantation.
The second surgical procedure begins approximately 1 week after the first operation.
After 2 years, treatments are compared. If transplant is shown to benefit Parkinson's disease, then patients who received placebo operation will be offered transplant surgery in the final year of the study.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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fetal nigral transplantation
Eligibility Criteria
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Inclusion Criteria
--Disease Characteristics-- Advanced Parkinson's disease Hoehn-Yahr stage IV or worse during "off" periods Hoehn-Yahr stage III or better during "on" periods Predictable motor fluctuations with at least 20% of waking day in the "off" stage No atypical parkinsonism or secondary parkinsonism --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Stable doses of levodopa/carbidopa or any other antiparkinson therapy for 2 months prior to study Surgery: No previous intracranial/neurosurgical procedures --Patient Characteristics-- Renal: Creatinine clearance at least 70 mL/min or creatinine no greater than 1.8 mg/dL Protein no greater than 300 mg/dL Other: Not pregnant or nursing Adequate contraception required of fertile patients Prior history of good response to levodopa No sensitivity to cyclosporine Not HIV positive (e.g., HIV I or II) No human T-cell leukemia/lymphoma virus (HTLV-1) No tremors interfering with stereotactic surgery No clinically significant medical, neoplastic or infectious disease No clinically significant laboratory abnormality No dementia that precludes signing informed consent or score of less than 24 on Mini-Mental status examination
35 Years
75 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
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C. Warren Olanow
Role: STUDY_CHAIR
Icahn School of Medicine at Mount Sinai
Other Identifiers
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MTS-94339
Identifier Type: -
Identifier Source: secondary_id
MTS-GCO-94-339
Identifier Type: -
Identifier Source: secondary_id
199/12102
Identifier Type: -
Identifier Source: org_study_id