Lemborexant Treatment of Insomnia Linked to Epilepsy | NCT06262594

Studies
Lemborexant Treatment of Insomnia Linked to Epilepsy

NCT06262594

Sponsor

University of Manitoba

Status

Recruiting

Last Update Posted

Feb 13, 2025Actual

Enrollment

26Estimated

Phase

Phase 3

Conditions

Epilepsy
Sleep

Interventions

Lemborexant
Placebo

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2024Actual

Primary Completion Date

Apr 18, 2026Estimated

Completion Date

Apr 18, 2027Estimated

First Submitted Date

Dec 21, 2023

First Submission Date that Met QC Criteria

Feb 14, 2024

First Posted Date

Feb 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2025

Last Update Posted Date

Feb 13, 2025Actual

Name	Class
Duke University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo First	Placebo Comparator	0mg	Drug: Lemborexant Drug: Placebo
Investigational Product First	Active Comparator	10mg qhs	Drug: Lemborexant Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lemborexant	Drug	Drug is administered	Investigational Product First Placebo First

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
WASO	Wake After Sleep Onset (recorded using PSG)	36 Days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marcus C Ng, MD, FRCPC	Contact	204-787-2684		letoile@umanitoba.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University	Not yet recruiting	Durham	North Carolina	27708	United States

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000634104	lemborexant

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided