Use of low-dose zolpidem in Parkinson's.

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 - Zolpidem for treatment of motor and cognitive deficits in Parkinson's

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004297-34-GB

Enrollment

Registered

2018-06-22

Start date

2018-03-31

Completion date

Unknown

Last updated

2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Stilnoct Product Name: Stilnoct Product Code: 207-3120 Pharmaceutical Form: Coated tablet INN or Proposed INN: Zolpidem Tartrate CAS Number: 99294-93-6 Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of idiopathic Parkinson’s and Hoehn and Yahr score of 2.5 or more. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14

Exclusion criteria

Exclusion criteria: Under the age of 40 years. Over the age of 80 years. Unable or unwilling to give informed consent Current therapy with CNS depressants Current therapy with CPY450 (CYP3A4) inhibitors or inducers Pregnancy History of psychiatric disorders History of alcohol or substance abuse Employed in a role that involves driving or operating heavy machinery Participating in another interventional clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine if a 5 mg dose of zolpidem is beneficial in reducing motor symptoms and cognitive deficits in late-stage Parkinson’s. ;Secondary Objective: To collect objective measures of motor performance including: testing of posture, gait, tremor and reaction times using a Smartphone application. This proof of concept study will collect quantitative data on safety and tolerance to support the design of a full Phase II trial of 5 mg of zolpidem for long-term treatment of motor symptoms and cognitive defects in late-stage Parkinson’s. ;Primary end point(s): Motor function measured using UPDRS.;Timepoint(s) of evaluation of this end point: Day 1 in clinic	—

Measure

Time frame

Main Objective: To determine if a 5 mg dose of zolpidem is beneficial in reducing motor symptoms and cognitive deficits in late-stage Parkinson’s. ;Secondary Objective: To collect objective measures of motor performance including: testing of posture, gait, tremor and reaction times using a Smartphone application. This proof of concept study will collect quantitative data on safety and tolerance to support the design of a full Phase II trial of 5 mg of zolpidem for long-term treatment of motor symptoms and cognitive defects in late-stage Parkinson’s. ;Primary end point(s): Motor function measured using UPDRS.;Timepoint(s) of evaluation of this end point: Day 1 in clinic

—

Secondary

Measure	Time frame
Secondary end point(s): cognitive function as assessed by verbal fluency tests Objective (Smartphone) testing of posture, gait, tremor and reaction time. ;Timepoint(s) of evaluation of this end point: cognitive verbal fluency tests - Day 1 in clinic Objective (Smartphone) testing - Day 2 to Day 7	—

Countries

United Kingdom

Contacts

Public ContactDirector AHRIC

Aston University

n.seare@aston.ac.uk01212043325

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026