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Use of Zolpidem in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Levodopa
Zolpidem first dose
Zolpidem second dose
sugar pill
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, zolpidem

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects will have Idiopathic Parkinson's disease according to diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank.
  • 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:

  • Neurodegenerative diseases.
  • 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.
  • Subjects who have undergone surgical procedures for PD but otherwise meet inclusion criteria will not be excluded a priori but evaluated on an individual basis.

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Arm Label

Sugar pill

Levodopa

Zolpidam second dose

Zolpidam first dose

Arm Description

Outcomes

Primary Outcome Measures

UPDRS
Unified Parkinson's Disease Rating Scale

Secondary Outcome Measures

Full Information

First Posted
May 9, 2011
Last Updated
November 30, 2012
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01351168
Brief Title
Use of Zolpidem in Parkinson's Disease
Official Title
A Randomized, Controlled, Double-Blind, Cross-over Study of Zolpidem for Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Withdrawn
Why Stopped
study not funded
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, zolpidem

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Title
Levodopa
Arm Type
Active Comparator
Arm Title
Zolpidam second dose
Arm Type
Experimental
Arm Title
Zolpidam first dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Levodopa
Other Intervention Name(s)
Sinemet
Intervention Description
CD/LD 25/100, 2 tablets test dose based on subject's current CD/LD dosing; single randomized testing day
Intervention Type
Drug
Intervention Name(s)
Zolpidem first dose
Other Intervention Name(s)
Ambien
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Zolpidem second dose
Other Intervention Name(s)
Ambien
Intervention Description
Zolpidem will be given at 7.5mg or 15 mg depending on the response from the first zolpidem dose.
Intervention Type
Drug
Intervention Name(s)
sugar pill
Other Intervention Name(s)
Placebo
Intervention Description
a sugar pill (placebo) will all be given orally in identical capsules to the other study drugs
Primary Outcome Measure Information:
Title
UPDRS
Description
Unified Parkinson's Disease Rating Scale
Time Frame
Subjects rated using the UPDRS at the Screening visit and then at each of the 4 study visits (1-2 weeks apart). During the study visits subjects will be rated every 30 minutes until they return to baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects will have Idiopathic Parkinson's disease according to diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank. 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: Neurodegenerative diseases. 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. Subjects who have undergone surgical procedures for PD but otherwise meet inclusion criteria will not be excluded a priori but evaluated on an individual basis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo Verhagen, MD PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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Use of Zolpidem in Parkinson's Disease

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