Use of Low-dose Zolpidem in Parkinson's Disease

• Status: Completed
• Trial end date: 2020-01-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aston University
• Collaborator: University Hospital Birmingham NHS Foundation Trust
• Treatments: Zolpidem

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.