- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03621046
Use of Low-dose Zolpidem in Parkinson's Disease
A Placebo Controlled Double Blind Randomised Controlled Proof of Concept Study of Zolpidem for the Treatment of Motor and Cognitive Deficits in Late-stage Parkinson's
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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West Midlands
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Birmingham, West Midlands, United Kingdom, B15 2TH
- University Hospitals Birmingham NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Zolpidem
A single oral zolpidem tablet (5 mg) administered in clinic and then each day for the following 3 days
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Zolpidem is a non-benzodiazepine sedative/hypnotic agent usually prescribed for insomnia.
Other Names:
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Placebo Comparator: Placebo
A single oral placebo administered in clinic and then each day for the following 3 days
|
Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in motor function
Time Frame: 1 day
|
In the clinic (day 1), motor function will be assessed before and after active/placebo administration using the Unified Parkinson's Disease Rating Scale (Part III).
This involves 26 assessments (scored 0-4) including of tremor, rigidity, agility and posture.
Scores therefore range from 0 to 104, the higher the score indicating reduced motor function.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in cognitive function
Time Frame: 1 day
|
In the clinic (day 1), cognitive function as measured by phonetic/letter fluency and semantic/category naming tasks. These test will be conducted on day 1 before and after active / placebo administration. The letter fluency test involves the participant giving as many different words as possible beginning with a specific letter, in 60 seconds. The category naming tasks involves the participant giving as many different examples from a given specific category (i.e, animals) in 60 seconds. The higher the score the greater the cognitive ability. |
1 day
|
Motor performance
Time Frame: 6 days
|
Objective measures of motor performance will be conducted using a mobile phone application specifically designed for Parkinson's patients (see Arora et al., 2015.
Parkinson's and Related Disorders 21; 650-653) which measures motor performance including: testing of posture; gait; tremor; and reaction times.
The testing protocol is for all patients (active and placebo) to perform tests 4 times per day on each of days 2 - 7, 3 days while taking drug/placebo, then 3 days not taking drug/placebo.
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6 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ian M Stanford, BSc, PhD, Aston University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Hypnotics and Sedatives
- GABA Agents
- Sleep Aids, Pharmaceutical
- GABA-A Receptor Agonists
- GABA Agonists
- Zolpidem
Other Study ID Numbers
- RRK6212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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