NCT06053840

An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Pharmanovia · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this Real-World Evidence trial is to establish whether short-term (2 weeks) treatment of Chloral Hydrate is effective in patients with severe insomnia which is interfering with normal daily life, and where other behavioural and pharmacologic therapies have failed in a real world setting.

Conditions

• Insomnia
• Insomnia Chronic
• Chloral Hydrate

Interventions

Type	Name	Description
DRUG	Chloral Hydrate	Participants will be involved in the trial for approximately 7-8 weeks, the first week to collect baseline data and complete screening and eligibility confirmation, the following two weeks they will administer IMP, and there will be a further 4 week observation period. All trial recruitment and follow-up procedures will be conducted remotely via telephone/video calls.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-04-24
• Completion: 2024-05-07
• First posted: 2023-09-26
• Last updated: 2024-11-07

Locations

1 site across 1 country: United Kingdom