Use of Zolpidem in Parkinson's Disease

This study has been withdrawn prior to enrollment.
(study not funded)
Sponsor:
Information provided by (Responsible Party):
Leonard Verhagen Metman, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01351168
First received: May 9, 2011
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: Levodopa
Drug: Zolpidem first dose
Drug: Zolpidem second dose
Drug: sugar pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double-Blind, Cross-over Study of Zolpidem for Patients With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Unified Parkinson's Disease Rating Scale


Enrollment: 0
Arms Assigned Interventions
Placebo Comparator: Sugar pill Drug: sugar pill
a sugar pill (placebo) will all be given orally in identical capsules to the other study drugs
Other Name: Placebo
Active Comparator: Levodopa 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
Experimental: Zolpidam second dose 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
Experimental: Zolpidam first dose 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

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351168

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Leo Verhagen, MD PhD Rush University Medical Center
  More Information

No publications provided

Responsible Party: Leonard Verhagen Metman, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01351168     History of Changes
Other Study ID Numbers: ZOL-PD
Study First Received: May 9, 2011
Last Updated: November 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Rush University Medical Center:
Parkinson's disease
zolpidem

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Zolpidem
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants
GABA-A Receptor Agonists
GABA Agonists
GABA Agents

ClinicalTrials.gov processed this record on August 21, 2014