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Lemborexant Treatment of Insomnia Linked to Epilepsy

Lemborexant Treatment of Insomnia Linked to Epilepsy

Recruiting
18 years and older
All
Phase 3

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Overview

The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.

Eligibility

Inclusion Criteria:

  • Sleep-related focal epilepsy
  • Contraception

Exclusion Criteria:

  • 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

Study details
    Epilepsy
    Sleep

NCT06262594

University of Manitoba

18 May 2024

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FAQs

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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