Recruiting
Phase 3

Lemborexant

Sponsor:

University of Manitoba

Code:

NCT06262594

Conditions

Epilepsy

Sleep

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lemborexant

Placebo

Study Details

Brief summary:

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

Conditions

Epilepsy

Sleep

Study ID

NCT06262594

Start date

Oct 29, 2024

Status verified date

Feb, 2025

Completion date

Apr 18, 2027

Anticipated

Primary completion date

Apr 18, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo First

0mg

active comparator: Investigational Product First

10mg qhs

Interventions

Lemborexant

Drug is administered

Placebo

Drug is administered

Primary outcome measure

  • WASO [ Time Frame: 36 Days ]

Central Contacts and Locations

Central contacts

Marcus C Ng, MD, FRCPC

204-787-2684letoile@umanitoba.ca

Locations

Health Sciences Centre

Recruiting

Winnipeg, Manitoba, Canada, R3A1R9

Contacts

Marcus Ng, MD, FRCPC

204-787-2684letoile@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Feb 13, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-02-13.