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Trial record 8 of 118 for:    ZOLPIDEM AND AIDS

Use of Zolpidem in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01351168
Recruitment Status : Withdrawn (study not funded)
First Posted : May 10, 2011
Last Update Posted : December 3, 2012
Sponsor:
Information provided by (Responsible Party):
Leonard Verhagen Metman, Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE May 9, 2011
First Posted Date  ICMJE May 10, 2011
Last Update Posted Date December 3, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2011)
UPDRS [ 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. ]
Unified Parkinson's Disease Rating Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01351168 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Zolpidem in Parkinson's Disease
Official Title  ICMJE A Randomized, Controlled, Double-Blind, Cross-over Study of Zolpidem for Patients With Parkinson's Disease
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: Levodopa
    CD/LD 25/100, 2 tablets test dose based on subject's current CD/LD dosing; single randomized testing day
    Other Name: Sinemet
  • 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
    Other Name: Ambien
  • Drug: Zolpidem second dose
    Zolpidem will be given at 7.5mg or 15 mg depending on the response from the first zolpidem dose.
    Other Name: Ambien
  • Drug: sugar pill
    a sugar pill (placebo) will all be given orally in identical capsules to the other study drugs
    Other Name: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Sugar pill
    Intervention: Drug: sugar pill
  • Active Comparator: Levodopa
    Intervention: Drug: Levodopa
  • Experimental: Zolpidam second dose
    Intervention: Drug: Zolpidem second dose
  • Experimental: Zolpidam first dose
    Intervention: Drug: Zolpidem first dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 30, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2011)
40
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01351168
Other Study ID Numbers  ICMJE ZOL-PD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leonard Verhagen Metman, Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leo Verhagen, MD PhD Rush University Medical Center
PRS Account Rush University Medical Center
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP