Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Sugar pill
sugar pill
a sugar pill (placebo) will all be given orally in identical capsules to the other study drugs
Levodopa
Levodopa
CD/LD 25/100, 2 tablets test dose based on subject's current CD/LD dosing; single randomized testing day
Zolpidam second dose
Zolpidem second dose
Zolpidem will be given at 7.5mg or 15 mg depending on the response from the first zolpidem dose.
Zolpidam first dose
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
Interventions
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Levodopa
CD/LD 25/100, 2 tablets test dose based on subject's current CD/LD dosing; single randomized testing day
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
Zolpidem second dose
Zolpidem will be given at 7.5mg or 15 mg depending on the response from the first zolpidem dose.
sugar pill
a sugar pill (placebo) will all be given orally in identical capsules to the other study drugs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects will be capable and willing to provide written informed consent prior to participation.
* Subjects will be ambulatory (in ON- and OFF-states) men and women, between the ages of 30 and 75 years.
* Subjects will be on levodopa therapy, with a good response and indisputable motor fluctuations.
* All other PD medications are allowed.
* Subjects will be on a stable regimen of PD medications for 2 weeks prior to screening.
* Subjects will be required to come with a caregiver who can accompany the subject to/from each study visit. Note: Subjects will not be allowed to drive home.
* Female subjects will be advised to use adequate birth control throughout the study as the effects of ZLP on the fetus are unknown. Adequate birth control methods include surgical sterilization, a partner who has had a vasectomy, oral contraceptives, condom plus spermicidal cream/jelly, cervical cap plus spermicidal cream/jelly, diaphragm plus spermicidal cream/jelly, or intrauterine device (in place for at least 3 months) plus spermicidal cream/jelly. Abstinence is considered an acceptable contraceptive regimen. If a subject becomes pregnant during the study, it is important that they contact the study physician immediately.
Exclusion Criteria
* Tremor predominant PD, with a score of \> 2 in more than one body part.
* Inability to tolerate being off levodopa for 12 hours.
* A score on the Montreal Cognitive Assessment (MoCA) of less than 26.
* Pregnancy or lactation.
* History of drug or alcohol abuse.
* Known or suspected sensitivity to the investigational study drugs.
* Other known medical or psychiatric condition that may compromise participation in the study or that judged by the site investigator could disqualify a subject from entering the study.
* Participation in another investigational drug study whereby they received experimental drug \< 30 days prior to start of this study.
30 Years
75 Years
ALL
No
Sponsors
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Rush University Medical Center
OTHER
Responsible Party
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Leonard Verhagen Metman
MD
Principal Investigators
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Leo Verhagen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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ZOL-PD
Identifier Type: -
Identifier Source: org_study_id