Phase 1 Narcolepsy Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
For all parts of the trial (Parts A, B, C, and D):
- Your resting heart rate (while lying down) is between 45 and 100 beats per minute, measured at two separate check-in visits.
For Parts A, B, and D only:
- Your body mass index (BMI — a measure based on your height and weight) is between 18.5 and 30.
- You have a regular sleep schedule, meaning you typically wake up between 6:00–9:00 a.m. and go to sleep between 9:00 p.m. and midnight.
- You are between 18 and 55 years old at the time of your first screening appointment.
For Part C only:
- Your BMI is between 18.5 and 35.
- You have been diagnosed with Type 1 Narcolepsy (a sleep disorder) according to recognised medical guidelines, and your diagnosis was made more than 3 months before your first screening appointment.
- You are between 18 and 64 years old at the time of your first screening appointment.
Who may not be able to join:
For all parts of the trial (Parts A, B, C, and D):
- You have previously taken part in this trial or received the study drug (Lu AH69593) before.
- You have taken part in any other clinical trial within the last 30 days before your screening appointment.
- You are pregnant, breastfeeding, planning to become pregnant, or are able to become pregnant and are not willing to use a reliable form of contraception.
- You have a history of cancer that has not been in remission for more than 5 years, with the exception of certain minor skin cancers or a treated cervical condition (confirm with trial site).
- You have worked night shifts or crossed more than 3 time zones within the 2 weeks before you would first receive the study drug.
- You train intensively for events such as marathons or triathlons, or compete in sport at a high level.
For Parts A, B, and D only:
- You have had a significant illness within the 4 weeks before you would first receive the study drug, and have not yet fully recovered.
For Parts B and C only:
- You are considered to be at significant risk of suicide, based on your medical history, a clinician's assessment, or your answers to a standard suicide risk questionnaire within the past 6 months (confirm with trial site).
For Part C only:
- You have another condition that would need to be treated first, before treating your narcolepsy, or that might interfere with this trial.
- You have a condition other than Type 1 Narcolepsy that also causes excessive daytime sleepiness.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Email contact via H. Lundbeck A/S, H. Lundbeck A/S
Phone: +45 36301311
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Number of Participants With Treatment-emergent Adverse Events (TEAEs); Bond Lader Visual Analogue Scale (VAS) dimension scores (Alertness, Contentedness, and Calmness); Psychomotor Vigilance Task (PVT) Parameter - Change From Baseline in Reaction Time to Stimuli; PVT Parameter - Change From Baseline in Number of Errors of Omission; PVT Parameter - Change From Baseline in Number of Errors of Commission (Response Without Stimulus); Number of Participants With Suicidal Ideation and Behaviour Based on the Columbia-Suicide Severity Rating Scale (C-SSRS); Area Under the Curve (AUC) From Zero to Time...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.