Double-blind Placebo Surgery Trial for Treatment of Parkinson's Disease
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - 75 |
| Updated: | 11/22/2017 |
| Start Date: | November 1994 |
| End Date: | February 1999 |
Transplantation of Embryonic Dopamine Neurons for Treatment of Parkinson's Disease: Double-blind Placebo Surgery Trial
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.
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.
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.
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.
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
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