Recruiting NCT06262594
Lemborexant Treatment of Insomnia Linked to Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lemborexant, Placebo.
- Who it may be relevant to
- Registry conditions: Epilepsy, Sleep. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.
Interventions
- Drug Lemborexant
Drug is administered - Drug Placebo
Drug is administered
Primary outcome measures
- WASO [Time frame: 36 Days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University — Durham
Canada · 1 center
- Health Sciences Centre — Winnipeg
Identifiers
NCT: NCT06262594 · L'ÉTOILE