Lemborexant Treatment of Insomnia Linked to Epilepsy (L'ÉTOILE)

University of Manitoba

Status and phase: Enrolling; Phase 3

Conditions: Epilepsy; Sleep

Treatments: Drug: Lemborexant; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06262594

L'ÉTOILE

Details and patient eligibility

About

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

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

Placebo First

Placebo Comparator group

Description:

0mg

Treatment:

Drug: Placebo

Drug: Lemborexant

Investigational Product First

Active Comparator group

Description:

10mg qhs

Treatment:

Drug: Placebo

Drug: Lemborexant