Use of Zolpidem in Parkinson's Disease
Information source: Rush University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: Levodopa (Drug); Zolpidem first dose (Drug); Zolpidem second dose (Drug); sugar pill (Drug)
Phase: Phase 2
Sponsored by: Rush University Medical Center
Official(s) and/or principal investigator(s):
Leo Verhagen, MD PhD, Principal Investigator, Affiliation: Rush University Medical Center
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
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.
Official title: A Randomized, Controlled, Double-Blind, Cross-over Study of Zolpidem for Patients With Parkinson's Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: UPDRS
Minimum age: 30 Years.
Maximum age: 75 Years.
- 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
- 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
- All other PD medications are allowed.
- Subjects will be on a stable regimen of PD medications for 2 weeks prior to
- 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.
- 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.
Locations and Contacts
Rush University Medical Center, Chicago, Illinois 60612, United States
Last updated: November 30, 2012