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Use of Zolpidem in Parkinson's Disease

NCT01351168 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-12-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Leo Verhagen, MD PhD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01351168 on ClinicalTrials.gov