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Use of Low-dose Zolpidem in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03621046
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
University Hospital Birmingham NHS Foundation Trust
Information provided by (Responsible Party):
Aston University

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Zolpidem Other: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A placebo controlled double-blinded proof-of-concept study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zolpidem
A single oral zolpidem tablet (5 mg) administered in clinic and then each day for the following 3 days
Drug: Zolpidem
Zolpidem is a non-benzodiazepine sedative/hypnotic agent usually prescribed for insomnia.
Other Name: Stilnoct

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621046


Contacts
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Contact: Nichola Seare, BSc +44 121 204 3325 N.Seare@aston.ac.uk
Contact: Matthew Richards, BSc +44 121 204 5069 m.richards3@aston.ac.uk

Locations
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United Kingdom
University Hospitals Birmingham NHS Foundation Trust Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Contact: Benjamin Wright, MBBS    0121 371 6890 ext 16890    benjamin.wright@uhb.nhs.uk   
Sponsors and Collaborators
Aston University
University Hospital Birmingham NHS Foundation Trust
Investigators
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Study Director: Ian M Stanford, BSc, PhD Aston University

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Responsible Party: Aston University
ClinicalTrials.gov Identifier: NCT03621046     History of Changes
Other Study ID Numbers: RRK6212
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Aston University:
motor;
cognition
Additional relevant MeSH terms:
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Central Nervous System Diseases
Nervous System Diseases
Zolpidem
Central Nervous System Depressants
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Movement Disorders
Neurodegenerative Diseases
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action