Double-blind Placebo Surgery Trial for Treatment of Parkinson's Disease

Completed · Not applicable · Has a placebo group

Conditions studied: Parkinson Disease, Surgery

In brief

A double-blind sham surgery-controlled trial was developed to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced Parkinson's disease (PD), with half the patients receiving the implant (n = 20) and half receiving sham surgery (n = 20). The blind was maintained for 12 months before participants were told which surgery they received, at which time those receiving sham surgery could request the implant surgery.

Key facts

Study ID

NCT03347955

Run by

University of Denver

People needed

40

Starts

1994-11-01

Expected to finish

1999-02-01

Last updated by the study team

2017-11-20

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with Parkinson's disease (PD) for more than 7 years, improvement in response to levodopa, Positive Emission Tomography scan compatible with presence of PD, improvement of at least 33% on UPDRS after first morning dose of levodopa

You may not qualify if…

• Mini-mental status exam score of less than 24, hallucinations during levodopa therapy, epilepsy, previous brain surgery, severe depression, another neurologic disorder, cardiovascular disease, and medical contraindication of surgery

Where it is running

• Morgridge College of Education, University of Denver — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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