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

NCT06053840 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Pharmanovia

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-04-24
Completion
2024-05-07

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053840 on ClinicalTrials.gov