Use of Low-dose Zolpidem in Parkinson's Disease

NCT03621046 | Completed Phase 2 DMC

• 1 other identifier: RRK6212
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Keywords

motor;; cognition

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (2)

• Changes in cognitive function

  1 day

• Motor performance

  6 days

Study Arms (2)

Zolpidem

EXPERIMENTAL

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

Drug: Zolpidem

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Zolpidem DRUG

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

Also known as: Stilnoct

Zolpidem

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aston University: lead
• University Hospital Birmingham NHS Foundation Trust: collaborator

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ian M Stanford, BSc, PhD

  Aston University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A placebo controlled double-blinded proof-of-concept study

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: August 8, 2018
• Study Start: August 20, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 24, 2020
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

GB (1)