Use of Low-dose Zolpidem in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2020-01-24

Brief Summary

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This study will evaluate the motor and cognitive benefits of low-dose zolpidem in Parkinson's.

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Detailed Description

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Zolpidem is a hypnotic drug which at sub-sedative doses has been shown to improve both motor and cognitive deficits in stroke, dementia and Parkinson's. This has led to the hypothesis that low-dose zolpidem will be effective in early-stage Parkinson's, delaying the need for dopamine-replacement interventions, as an adjunct therapy, and in late-stage Parkinson's where current interventions are ineffective for motor and cognitive decline. At present, the symptoms of late-stage Parkinson's are the most debilitating and the least well-controlled. Here, the investigators propose a placebo controlled double-blinded proof-of-concept study in order to determine the benefits of taking low-dose zolpidem in late-stage Parkinson's. The study will take place over 12 months. 28 participants, diagnosed with Parkinson's for at least 5 years will be recruited; 14 participants will take zolpidem (5 mg) and 14 placebo, each morning for 4 days. In the clinic (day 1) clinical assessments will include the motor III of the Unified Parkinson's Disease Rating Scale (UPDRS) and cognitive verbal fluency tasks which will be conducted at baseline and 1 hour following drug administration. Each participant will then be issued with a smartphone with application to objectively test their motor performance 4 times a day, over the next six days (3 days on drug, 3 days off drug). This study will provide the necessary data on drug efficacy in order to design a phase II clinical trial for the use of low-dose zolpidem in late-stage Parkinson's.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A placebo controlled double-blinded proof-of-concept study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zolpidem

A single oral zolpidem tablet (5 mg) administered in clinic and then each day for the following 3 days

Group Type EXPERIMENTAL

Zolpidem

Intervention Type DRUG

Zolpidem is a non-benzodiazepine sedative/hypnotic agent usually prescribed for insomnia.

Placebo

A single oral placebo administered in clinic and then each day for the following 3 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Zolpidem

Zolpidem is a non-benzodiazepine sedative/hypnotic agent usually prescribed for insomnia.

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Stilnoct

Eligibility Criteria

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Inclusion Criteria

Diagnosis of idiopathic Parkinson's and Hoehn and Yahr score of 2.5 or more; Willing to participate and refrain from driving whist taking zolpidem/placebo; Within age range 40 to 80 years.

Exclusion Criteria

Any contraindications as stated in Summary of Product Characteristics (SmPC) for zolpidem:- Hypersensitivity to zolpidem tartrate; Obstructive sleep apnoea; Myasthenia gravis; Severe hepatic insufficiency; Acute and/or severe respiratory depression; Psychotic illness.

and in addition: - Unable or unwilling to give informed consent ; Current therapy with central nervous system (CNS) depressants; Current therapy with Cytochrome P450 (CPY450) inhibitors or inducers (specifically CYP3A4); Pregnancy and breast feeding women; History of alcohol or substance abuse; Employed in a role that involves driving or operating heavy machinery; Participation in another interventional clinical trial.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No