Use of Zolpidem in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

A Randomized, Controlled, Double-Blind, Cross-over Study of Zolpidem for Patients With Parkinson's Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01351168
• Other study ID #: ZOL-PD
• Status: Withdrawn
• Phase: Phase 2
• First received: May 9, 2011
• Last updated: November 30, 2012

Study information

• Verified date: November 2012
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Levodopa
CD/LD 25/100, 2 tablets test dose based on subject's current CD/LD dosing; single randomized testing day
• 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
• Zolpidem second dose
Zolpidem will be given at 7.5mg or 15 mg depending on the response from the first zolpidem dose.
• sugar pill
a sugar pill (placebo) will all be given orally in identical capsules to the other study drugs

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDRS	Unified Parkinson's Disease Rating Scale	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.	No