NCT06262594

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_3

Timeline
11mo left

Started Oct 2024

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Oct 2024Apr 2027

First Submitted

Initial submission to the registry

December 21, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

October 29, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2027

Expected
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

December 21, 2023

Last Update Submit

February 10, 2025

Conditions

EpilepsySleep

Outcome Measures

Primary Outcomes (1)

  • WASO

    Wake After Sleep Onset (recorded using PSG)

    36 Days

Study Arms (2)

Placebo First

PLACEBO COMPARATOR

0mg

Drug: LemborexantDrug: Placebo

Investigational Product First

ACTIVE COMPARATOR

10mg qhs

Drug: LemborexantDrug: Placebo

Interventions

LemborexantDRUG

Drug is administered

Also known as: Dayvigo
Investigational Product FirstPlacebo First
PlaceboDRUG

Drug is administered

Investigational Product FirstPlacebo First

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sleep-related focal epilepsy
  • Contraception

You may not qualify 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University

Durham, North Carolina, 27708, United States

NOT YET RECRUITING

Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Marcus C Ng, MD, FRCPC

CONTACT

204-787-2684letoile@umanitoba.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2023

First Posted

February 16, 2024

Study Start

October 29, 2024

Primary Completion

April 18, 2026

Study Completion (Estimated)

April 18, 2027

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations

CA(1)US(1)