Clinical trial NCT01351168: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
zolpidem
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2011-05-10
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: UPDRS
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Leo Verhagen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: