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

Parkinson Disease Clinical Trial

Official title: Transplantation of Embryonic Dopamine Neurons for Treatment of Parkinson's Disease: Double-blind Placebo Surgery Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

A double-blind sham surgery-controlled trial was conducted 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 goals were to determine whether the cells survived and led to improvement of symptoms, and to examine the effect of age on results of the implantation. Quality of life of participants and care partners was also examined at each of the assessment periods (baseline, 4, 8 and 12 months). The blind was maintained for 12 months. ;

Related Conditions & MeSH terms

• Parkinson Disease
• Surgery

• NCT number: NCT03347955
• Study type: Interventional
• Source: University of Denver
• Status: Completed
• Phase: N/A
• Start date: November 1994
• Completion date: February 1999