Embryonic Dopamine Cell Implants for Parkinson's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT00038116

Run by

University of Colorado, Denver

People needed

40

Starts

1995-05-01

Expected to finish

2009-08-01

Last updated by the study team

2013-02-05

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Idiopathic Parkinson's disease of at least 7 years duration and responsive to levodopa. Other Parkinson syndromes excluded.
• Patients previously tried on other available forms of medical treatment.
• Age between 20 and 75 years.
• Presence of an intractable problem, such as "off" periods, dyskinesias, or "freezing," not controlled by dopamine agonists such as levodopa or pergolide.
• No serious depression and no cognitive impairment.
• Successful completion of home diary by patient or responsible party.
• Successful videotape recordings at home of "on" and "off" status.
• Normal MRI of brain within the last 18 months.
• Fluorodopa PET scan compatible with idiopathic Parkinson's disease.
• Medically fit to undergo implant surgery with certification by the patient's physician.
• Able to financially cover expenses not paid for by NIH grant (between $1,000 and $2,000 for unreimbursed travel, video camera, and blood screening as specified in the consent form.

You may not qualify if…

• Severe or moderately severe depression or cognitive impairment.
• Previous brain surgery.
• Presence of diabetes mellitus, severe cardiopulmonary disease or other severe medical disease, or MRI evidence of cerebrovascular disease.
• Not medically cleared to undergo a surgical procedure.

Where it is running

• University Hospital, the University of Colorado Health Sciences Center — Denver, Colorado, United States
• North Shore University Hospital — Manhasset, New York, United States
• The Movement Disorder Center, Columbia-Presbyterian Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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