NCT03347955

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Denver · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Parkinson Disease
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Neural implantation group	Cultured mesencephalic tissue from four embryos was implanted into the putamen bilaterally for those receiving the implant
PROCEDURE	Sham surgery	Steel frame affixed to head and four burr holes drilled into forehead of sham surgery patients

Timeline

• Start date: 1994-11-01
• Primary completion: 1999-02-01
• Completion: 1999-02-01
• First posted: 2017-11-20
• Last updated: 2017-11-20

Locations

1 site across 1 country: United States