Use of Low-dose Zolpidem in Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03621046|
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: Zolpidem Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A placebo controlled double-blinded proof-of-concept study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
A single oral zolpidem tablet (5 mg) administered in clinic and then each day for the following 3 days
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
- 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.
- 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.
- 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.
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
|Contact: Nichola Seare, BSc||+44 121 204 3325||N.Seare@aston.ac.uk|
|Contact: Matthew Richards, BSc||+44 121 204 email@example.com|
|University Hospitals Birmingham NHS Foundation Trust||Recruiting|
|Birmingham, West Midlands, United Kingdom, B15 2TH|
|Contact: Benjamin Wright, MBBS 0121 371 6890 ext 16890 firstname.lastname@example.org|
|Study Director:||Ian M Stanford, BSc, PhD||Aston University|