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

NCT03347955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-11-20

No results posted yet for this study

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.

Conditions

  • Parkinson Disease
  • Surgery

Interventions

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

Sponsors & Collaborators

  • University of Denver

    lead OTHER

Principal Investigators

  • Cynthia McRae, PhD · University of Denver

  • Stanley Fahn, MD · Neurological Institute, Columbia University

  • Curt Freed, MD · University of Colorado Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-11-30
Primary Completion
1999-02-28
Completion
1999-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03347955 on ClinicalTrials.gov