Randomized Study of Fetal Neurotransplantation for the Treatment of Parkinson's Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

July 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004844 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Randomized Study of Fetal Neurotransplantation for the Treatment of Parkinson's Disease

Official Title ^ICMJE

Brief Summary

OBJECTIVES:

I. Assess the safety and efficacy of embryonic mesencephalic dopamine cell implants into the putamen of patients with Parkinson's disease.

Detailed Description

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are stratified by age (over and under 60). Patients are randomized to receive either sham surgery or tissue implantation.

Embryonic tissue is prepared. While patients are awake, but sedated, bilateral incisions are made in the skin and burr holes drilled in the skull. A cannula is inserted into the brain to the posterior putamen. Implant patients receive embryonic neural tissue or sham patients have no needles penetrate the brain. After 1 year, patients who receive the sham operation in the first operation may receive embryonic neural tissue in a second operation.

Patients are followed every 4 months during the first year and every 6 months thereafter.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Condition ^ICMJE

Parkinson Disease

Intervention ^ICMJE

Procedure: tissue implantation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Idiopathic Parkinson's disease for at least 7 years with rest tremor or bradykinesia and one of the following cardinal signs: Rigidity Flexed posture Loss of postural reflexes Freezing (motor blocks)
Continuing response to levodopa
Presence of at least one of the following intractable symptoms or signs: Intractable disabling fluctuations Intractable disabling dyskinesias Intractable "on" freezing (i.e., motor blocks that interfere with walking despite being "on"
Bilateral parkinsonism when "off" (may be asymmetry between right and left sides)
Decreased dopa uptake in the striatum

--Prior/Concurrent Therapy--

No prior brain surgery

--Patient Characteristics--

Cardiovascular: No severe cardiopulmonary disease
Neurologic: No history of strokes No neuroleptics No encephalitis No oculogyric crisis No remission No cerebellar signs No dementia (Mini-Mental state score no greater than 22) No supranuclear gaze palsy No Babinski sign No orthostatic hypotension No hydrocephalus No brain tumor No occlusive cerebrovascular disease
Pulmonary: Absolute standing pressure at least 90/60 mmHg
Other: No diabetes mellitus No exposure to toxins No other severe medical disease Hamilton Depression Scale score of less than 20 points

Gender

Both

Ages

40 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004844

Responsible Party

Study ID Numbers ^ICMJE

199/13940, UCHSC-COMIRB-9397

Study Sponsor ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators ^ICMJE

University of Colorado at Denver and Health Sciences Center

Investigators ^ICMJE

Study Chair:

Curt R. Freed

University of Colorado at Denver and Health Sciences Center

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

January 1999

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP