Recommended

Teva close to API business sale
First new IPF treatment in US for a decade
Webinar: Radiopharmaceuticals’ time-to-result challenge
AstraZeneca/Daiichi cancer drug boost
Takeda to move away from cell therapy
GSK appoints new CEO
news

Innovative insomnia study aims to overcome major clinical trial bottleneck

2
SHARES

A new UK trial investigating a standard insomnia treatment is a “significant step forward in patient-centric trial design”.

chloral hydrate-clinical trial

For UK patients with severe insomnia, for whom existing therapies have not worked, a new, decentralised clinical trial is set to evaluate chloral hydrate as a short-term treatment.

 

Reserve your FREE place

 


Address the time-to-result challenge posed by short shelf-life radiopharmaceuticals.

20 November 2025 | 3:00 PM GMT | FREE Virtual Panel Discussion

This webinar showcases the Growth Direct System; an RMM (Rapid Microbial Method) that improves on traditional membrane filtration, delivering increased accuracy, a faster time to result, enhanced data integrity compliance, and more control over the manufacturing process.

Key learning points:

  • Understand the benefits of full workflow microbiology quality control testing automation in radiopharmaceutical production
  • Learn about ITM’s implementation journey and considerations when evaluating the technology
  • Find out how the advanced optics and microcolony detection capabilities of Growth Direct® technology impact time to result (TTR).

Don’t miss your chance to learn from experts in the industry – Register for FREE

 

Evaluating chloral hydrate for insomnia

While chloral hydrate is already an established treatment for insomnia, much of the published clinical data in adult patients is dated, according to clinical trials company Lindus Health and global lifecycle management healthcare company Pharmanovia.

Therefore, the companies have stated they aim to generate fresh data on the safety and efficacy of this treatment, using more current validated trial endpoints.

Survey reports untapped potential for UK clinical trials

By adopting this innovative approach, the goal is to reduce the challenges and obstacles associated with in-clinic studies and enables a more diverse range of participants.

According to Lindus Health and Pharmanovia, the first of 90 people aged 18-75 with severe insomnia set to be involved in the trial, has been enrolled. For the patients, the study will involve a fortnight of chloral hydrate treatment, followed by four weeks follow-up. Dosage will be dependent on previous treatment and will be titrated during the study.

The trial represents a “significant step forward in patient-centric trial design, as it seeks to leverage insights from patient-reported outcomes (PROs) using digital self-assessment methods such as online questionnaires and digital tools such as telemedicine and virtual pharmacies.”

“Traditional clinical trials have been the biggest bottleneck in improving human health, from the soaring costs to the lengthy time frame needed for approvals, so we are excited to help accelerate the pace of research [through the decentralised trial]”

There is “enormous value” in patient-centric insights through decentralised trials, according to the co-founder of Lindus Health, Michael Young.

“Traditional clinical trials have been the biggest bottleneck in improving human health, from the soaring costs to the lengthy time frame needed for approvals, so we are excited to help accelerate the pace of research to find an alternative treatment for people living with severe insomnia,” Young added.

Patients participating in the trial will be closely monitored by a virtual clinical team as well as an independent Data Safety Monitoring Board (DSMB).

Digitalisation of the clinical trial landscape

Share via
Share via