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Investigational Product First for Sleep (L'ÉTOILE Trial)

Phase 3

Recruiting

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sleep-related focal epilepsy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 days

Awards & highlights

L'ÉTOILE Trial Summary

This trial aims to see if a medication called Lemborexant can help improve the sleep of people with epilepsy.

Who is the study for?

This clinical trial is for individuals who have sleep-related focal epilepsy and are willing to use contraception. It's not specified, but typically participants would need to be in good general health aside from their epilepsy and insomnia.Check my eligibility

What is being tested?

The trial is testing Lemborexant, a potential treatment for insomnia in people with epilepsy. Participants will either receive Lemborexant or a placebo (a pill without any active drug) to see if there's an improvement in sleep.See study design

What are the potential side effects?

While the side effects of Lemborexant aren't listed here, common ones may include drowsiness during the day, headaches, dizziness, and potentially worsening of depression or suicidal thoughts.

L'ÉTOILE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have epilepsy that occurs during sleep.

L'ÉTOILE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

WASO

L'ÉTOILE Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Investigational Product FirstActive Control2 Interventions

10mg qhs

Group II: Placebo FirstPlacebo Group2 Interventions

0mg

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor

597 Previous Clinical Trials

199,453 Total Patients Enrolled

1 Trials studying Sleep

30 Patients Enrolled for Sleep

Duke UniversityOTHER

2,377 Previous Clinical Trials

3,427,140 Total Patients Enrolled

5 Trials studying Sleep

1,193 Patients Enrolled for Sleep

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still being enrolled for participation in this clinical trial?

"Indeed, as per clinicaltrials.gov data, this trial is actively seeking participants. The initial posting date was April 18th, 2024, with the latest update on May 6th of the same year. The research study aims to enroll a total of 26 individuals at one designated site."

Answered by AI

Has the investigational product been granted FDA approval previously?

"Based on the assessment by our team at Power, Investigational Product First has been rated as a level 3 in terms of safety. This designation is due to its Phase 3 trial status and the presence of data confirming both efficacy and repeated instances of safety verification."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical research study?

"Affirmative. Information on clinicaltrials.gov indicates that this investigation is presently in the recruitment phase. Initially shared on April 18, 2024, and last modified on May 6, 2024, the trial aims to enlist a total of 26 volunteers from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lemborexant Treatment of Insomnia Linked to Epilepsy

2024. "Lemborexant Treatment of Insomnia Linked to Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06262594.

All > Epilepsy