Parkinson DiseasePhase 2NCT03621046
Use of Low-dose Zolpidem in Parkinson's Disease
A Phase 2 study testing Zolpidem in people with Parkinson Disease, run by Aston University at 1 site in United Kingdom.
Trial summary
This study will evaluate the motor and cognitive benefits of low-dose zolpidem in Parkinson's. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Aug 2018to 24 Jan 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TH
About this study
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
This study will evaluate the motor and cognitive benefits of low-dose zolpidem in Parkinson's.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Zolpidem, Placebo
- Keywords
- motor;, cognition
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolpidemDrug
Also called Stilnoct
Zolpidem is a non-benzodiazepine sedative/hypnotic agent usually prescribed for insomnia.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Zolpidem | Experimental | A single oral zolpidem tablet (5 mg) administered in clinic and then each day for the following 3 days Receives: Drug: Zolpidem |
| Placebo | Placebo comparator | A single oral placebo administered in clinic and then each day for the following 3 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in motor function
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.
Measured: 1 day
Secondary outcomes (2)
Changes in cognitive function
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.
Measured: 1 day
Motor performance
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.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start20 Aug 2018
- Primary completion31 Dec 2019
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A placebo controlled double-blinded proof-of-concept study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Ian M Stanford, BSc, PhD, Study director, Aston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621046
- Sponsor's protocol ID
- RRK6212
- Status last verified
- Mar 2020
- First submitted
- 6 Jun 2018
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03621046
- Acronym / sponsor ID
- RRK6212
- Conditions
- Parkinson Disease
- Keywords
- motor;, cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Collaborators
- University Hospital Birmingham NHS Foundation Trust
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the motor and cognitive benefits of low-dose zolpidem in Parkinson's.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A placebo controlled double-blinded proof-of-concept study
| Arm | Type | Receives |
|---|---|---|
| Zolpidem | Experimental | Drug: ZolpidemA single oral zolpidem tablet (5 mg) administered in clinic and then each day for the following 3 days |
| Placebo | Placebo comparator | Other: PlaceboA single oral placebo administered in clinic and then each day for the following 3 days |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZolpidemAlso: StilnoctZolpidem is a non-benzodiazepine sedative/hypnotic agent usually prescribed for insomnia. | Drug | Zolpidem |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
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.
2 secondary outcomes
Changes in cognitive function
Time frame: 1 day
Motor performance
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian M Stanford, BSc, PhD study director
Aston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zolpidem in people with Parkinson Disease, run by Aston University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in motor function (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.