Summary: Pharmanovia, in partnership with Lindus Health, announced positive topline results from its open-label RESTORE trial on chloral hydrate for severe insomnia. The trial, which involved 100 adult patients receiving chloral hydrate over 14 days, demonstrated improvements in insomnia severity and quality of life, with benefits persisting for up to four weeks post-treatment. The study used validated patient-reported outcomes to assess safety, tolerability, and efficacy. No serious adverse effects were reported.
Key Takeaways:
- Efficacy in Severe Insomnia: Chloral hydrate significantly reduced insomnia severity, as shown by a marked decrease in Insomnia Severity Index scores after two weeks of treatment for patients in which behavioral and pharmacologic therapies have failed.
- Quality of Life Improvements: Patient-reported outcomes indicated enhanced sleep quality and improvements in quality-of-life measures, with some benefits persisting up to four weeks post-treatment.
- Real-World Insights: The decentralized trial design and use of more current, validated trial endpoints provided real-world evidence supporting chloral hydrate’s safety and efficacy for severe insomnia treatment, according to investigators.
Pharmanovia, a global pharmaceutical company, announced positive topline results of its open-label RESTORE trial in severe insomnia, in partnership with Lindus Health.
A topline readout using patient-reported outcomes has found that short-term use of chloral hydrate, a mild hypnotic originally developed in the 19th century, shows benefit in people with severe insomnia where it is interfering with normal daily life and when other therapies (behavioral and pharmacologic) have failed.
The trial enrolled 100 adult patients who received chloral hydrate treatment over 14 days and came from primary and secondary care sites. Patients were closely monitored by a virtual team of secondary care sleep specialists, as part of the decentralised trial design, and were assessed for the safety, tolerability and identification of baseline characteristics, changes in sleep and quality of life outcomes.
The topline readout found that chloral hydrate significantly improved insomnia symptoms in adults with severe insomnia. The primary efficacy endpoint, change in Insomnia Severity Index score from baseline after two weeks of treatment, decreased significantly after 14 days of treatment and no serious adverse effects were reported.
Various patient-reported measures of sleep showed significant improvements in quality-of-life measures, and some improvements persisted up to four weeks after treatment ended. Sleep quality improvement was seen by a change in Pittsburgh Sleep Quality Index score after two weeks of treatment.
“We are delighted with the topline results of the RESTORE trial. As a company dedicated to improving health through reinvigorating established medicines and generating new clinical data, we welcome these findings showing that chloral hydrate, an established product licensed for severe insomnia, is effective not just in short-term treatment but has longer-term benefits after treatment has stopped at two weeks for patients with severe insomnia which is interfering with normal daily life and where other therapies (behavioral and pharmacologic) have failed,” says Stephen Deacon, chief scientific officer at Pharmanovia, in a release.
New Data on Efficacy of Chloral Hydrate for Insomnia
Current standards of care, including behavioral and traditional pharmacologic therapies, do not meet the needs of all people with insomnia, especially those with severe insomnia, according to a release from Pharmanovia.
While chloral hydrate is already an established treatment for insomnia, much of the published clinical data in adult patients is dated. These results have generated fresh data on the efficacy of this treatment, in a real-world setting, using, more current, validated trial endpoints and contemporary quality-of-life measures.
This is the first decentralised trial that Pharmanovia has conducted, in partnership with its clinical trials partner, Lindus Health. The fresh data and insights generated on the safety and efficacy of chloral hydrate, demonstrate the value of real-world evidence using patient-reported outcomes.
“We see lots of barriers to getting patients living with severe insomnia the treatment they need. Today’s study outcomes are a welcome step forward for people living with severe insomnia. The reduction in the severity of insomnia along with improvements in the quality of life demonstrate the effectiveness of chloral hydrate in the treatment of severe insomnia and provides patients with another option when other treatments have failed,” says professor Adrian Williams, chief investigator, Queen Victoria Hospital NHS Foundation Trust, in a release.
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