NCT01351168

Use of Zolpidem in Parkinson's Disease

A Randomized, Controlled, Double-Blind, Cross-over Study of Zolpidem for Patients With Parkinson's Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Levodopa treatment is associated with long-term complications. Dopamine deficiency is associated with abnormal activity in certain parts of the brain. Zolpidem may change this abnormal activity and, by doing so, may work in a different way than levodopa to help parkinsonism. The working hypothesis for this aim is that ZLP is superior to placebo in acutely improving motor symptoms of PD. The investigators will conduct a randomized,controlled, double-blind, cross-over study in 40 patients with PD. Each patient will receive placebo, levodopa and 2 doses of ZLP in a randomized order on 4 different occasions, about one week apart.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Levodopa	CD/LD 25/100, 2 tablets test dose based on subject's current CD/LD dosing; single randomized testing day
DRUG	Zolpidem first dose	Zolpidem will be given at 10 mg on randomized testing day. The randomization is such that the first dose of Zolpidem given to any subject will always be 10 mg
DRUG	Zolpidem second dose	Zolpidem will be given at 7.5mg or 15 mg depending on the response from the first zolpidem dose.
DRUG	sugar pill	a sugar pill (placebo) will all be given orally in identical capsules to the other study drugs

Timeline

• First posted: 2011-05-10
• Last updated: 2012-12-03

Locations

1 site across 1 country: United States