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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347955
• Other study ID #: R29NS032009-05
• Status: Completed
• Phase: N/A
• First received: November 13, 2017
• Last updated: November 15, 2017
• Start date: November 1994
• Est. completion date: February 1999

Study information

• Verified date: November 2017
• Source: University of Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1999
• Est. primary completion date: February 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Parkinson Disease
• Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Morgridge College of Education, University of Denver	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Denver

Country where clinical trial is conducted

United States, 

References & Publications (2)

Freed CR, Greene PE, Breeze RE, Tsai WY, DuMouchel W, Kao R, Dillon S, Winfield H, Culver S, Trojanowski JQ, Eidelberg D, Fahn S. Transplantation of embryonic dopamine neurons for severe Parkinson's disease. N Engl J Med. 2001 Mar 8;344(10):710-9. — View Citation

McRae C, Cherin E, Yamazaki TG, Diem G, Vo AH, Russell D, Ellgring JH, Fahn S, Greene P, Dillon S, Winfield H, Bjugstad KB, Freed CR. Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial. Arch Gen Psychiatry. 2004 Apr;61(4):412-20. Erratum in: Arch Gen Psychiatry. 2004 Jun;61(6):627. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Rating Scale	one item scale where participants marked their answer on a scale ranging from -3 (much worse since surgery) to 0 (no change) to +3 (much improved since surgery)	Same scale was administered 7 days after surgery and prior to follow-up visits at Columbia at 4, 8, and 12 months after surgery and before the blind was lifted.

External Links

•   Neurological and medical results of double-blind fetal transplant surgery as treatment for Parkinson's disease
•   Quality of life report on double-blind fetal transplant surgery for treatment of Parkinsons disease