Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06262594

Lemborexant Treatment of Insomnia Linked to Epilepsy

Led by University of Manitoba · Updated on 2025-02-13

26

Participants Needed

2

Research Sites

128 weeks

Total Duration

On this page

Sponsors

U

University of Manitoba

Lead Sponsor

D

Duke University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Lemborexant Treatment of Insomnia Linked to Epilepsy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Sleep-related focal epilepsy
  • Use of contraception
Not Eligible

You will not qualify if you...

  • Changes in antiseizure medication 1 month before or during the study
  • Use of concomitant medications per SUNRISE1
  • Hepatic impairment
  • Female participants who are pregnant or breastfeeding
  • Compromised respiratory function
  • History of complex sleep-related behaviour
  • Rare hereditary diseases such as galactosemia or glucose-galactose malabsorption
  • History of dependence, tolerance, abuse, or rebound insomnia
  • Psychiatric disorders with abnormal thinking, behavioural changes, depression, or suicidal ideation
  • Diagnosis of narcolepsy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Duke University

Durham, North Carolina, United States, 27708

Not Yet Recruiting

2

Health Sciences Centre

Winnipeg, Manitoba, Canada, R3A1R9

Actively Recruiting

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Research Team

M

Marcus C Ng, MD, FRCPC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Lemborexant Treatment of Insomnia Linked to Epilepsy | DecenTrialz