Recruiting PHASE3 Epilepsy

New treatment option for Epilepsy

Official title Lemborexant Treatment of Insomnia Linked to Epilepsy

ClinicalTrials.gov ID: NCT06262594

What this study is testing

What is Lemborexant?

Lemborexant is an investigational medicine, being studied as a potential treatment for epilepsy.

Also referred to as Dayvigo.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Sleep-related focal epilepsy
  • Contraception

You likely can't join if

  • Changes in antiseizure medication 1 month before study protocol or during study protocol
  • Concomitant medications per SUNRISE1
  • Individuals with hepatic impairment
  • Female participants who are pregnant or breastfeeding
  • Individuals with compromised respiratory function
  • Individuals with a history of complex sleep-related behaviour
See the full eligibility criteria
Who can join
  • Sleep-related focal epilepsy
  • Contraception
What rules you out
  • Changes in antiseizure medication 1 month before study protocol or during study protocol
  • Concomitant medications per SUNRISE1
  • Individuals with hepatic impairment
  • Female participants who are pregnant or breastfeeding
  • Individuals with compromised respiratory function
  • Individuals with a history of complex sleep-related behaviour
  • Individuals with rare hereditary diseases of galactose intolerance such as galactosemia or glucose-galactose malabsorption
  • Individuals with a history of dependence or tolerance - abuse, dependence, rebound insomnia
  • Individuals with psychiatric disorders with abnormal thinking and behavioural changes, depression, or suicidal ideation
  • Individuals with a diagnosis of narcolepsy

The study team makes the final eligibility decision.

Where it's taking place

  • Durham, North Carolina, United States
  • Winnipeg, Manitoba, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Durham, North Carolina, United States; Winnipeg, Manitoba, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.