Clinical trials startup Lindus Health is teaming up with global lifecycle management healthcare company Pharmanovia to launch an innovative new trial to generate fresh data and insights on the safety and efficacy of licensed chloral hydrate as a short-term treatment for severe insomnia.

This 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. By adopting this innovative approach, the study aims to reduce the challenges and barriers associated with in-clinic studies and enables a more diverse range of participants, who can continue with their day-to-day lives with minimal disruption.

The trial will combine Pharmanovia’s capabilities in clinical development while leveraging Lindus Health’s innovative end-to-end trial platform that will also include patient recruitment through primary care networks. Patients participating in the trial will be closely monitored by a virtual team of secondary care sleep specialists, responsible for diagnosing and overseeing treatment of severe insomnia. Moreover, an independent Data Safety Monitoring Board (DSMB) of specialists will also be monitoring patient safety.

It is estimated that around one in three people live with insomnia, and one in ten have severe forms of the disorder, making this a highly prevalent condition that impacts a person’s quality of life¹.

Chloral hydrate is already an established treatment for insomnia, however much of the published clinical data in adult patients is dated. There is therefore a need to gather fresh data on the efficacy of this treatment using more current validated trial endpoints and modern quality-of-life measures. The primary aim of this trial is to establish, in a real-world setting, whether short-term treatment of chloral hydrate is effective in patients with severe insomnia, which is interfering with normal daily life, and where other therapies (behavioural and pharmacologic) have failed².

Professor Adrian Williams FRCP FAASM, Professor of Sleep Medicine and Consultant Physician: “This is an important trial seeking to improve the quality of life for people living with severe insomnia where other treatments have failed. Through leveraging patient-reported outcomes to generate new data on the efficacy and quality of life measures of chloral hydrate, we aim to glean crucial patient insights that can ultimately help us to provide better care and improve patient outcomes.”

Michael Young, Co-Founder of Lindus Health, said: “As experts in end-to-end clinical trial design, we understand the enormous value of patient-centric insights through decentralised trials. 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’re excited to help accelerate the pace of research to find an alternative treatment for people living with severe insomnia. We’re delighted to work with Pharmanovia and pave the way for transforming healthcare through innovative clinical development.”

Steve Deacon, Chief Scientific Officer, Pharmanovia added: “At Pharmanovia we’re always looking at innovative ways to solve unmet needs in patients. This pioneering partnership with Lindus Health strengthens our versatility in clinical development and trial conduct and sets a precedent for a more patient-centric approach throughout the industry.”

References

 ¹ NHS approves first nightly pill to treat chronic insomnia – The Telegraph

² Prevalence of chronic insomnia in adults – Johns Hopkins Medicine