se of low-dose zolpidem in Parkinson's.

Phase 1

• Conditions: Parkinson's Disease; MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-004297-34-GB
• Lead Sponsor: Aston University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-22
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>;Secondary Objective: To collect objective measures of motor performance including: testing of posture, gait, tremor and reaction times using a Smartphone application. <br><br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): cognitive function as assessed by verbal fluency tests <br><br>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<br><br>Objective (Smartphone) testing - Day 2 to Day 7