Phase 3 Sleep Disorders Trial, Recruiting NCT06366464 Sponsor: Harmony Biosciences Management, Inc. Condition: Sleep Disorders
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Phase 3 Sleep Disorders Trial, Recruiting

NCT06366464
Recruiting Phase 3 🇦🇺 Australian site

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:

  • People who have been diagnosed with Prader-Willi Syndrome (PWS) confirmed through genetic testing.
  • People who experience excessive sleepiness during the day.
  • People who have a consistent parent or caregiver (ideally the same person throughout the whole study) who is willing and able to complete the required study assessments.
  • People whose parent(s), caregiver(s), or legal guardian(s) are considered by the study doctor to be capable of understanding and following the study requirements, including giving the oral study medication.

Who may not be able to join:

  • People who have been diagnosed with sleep apnea (either obstructive or central) that is not well managed or controlled.
  • People whose excessive sleepiness is caused by another sleep condition or medical condition.
  • People who have taken part in another clinical trial involving an investigational medication, device, or behavioural treatment within the last 30 days or 5 half-lives of that medication (whichever is the longer period) before the screening visit.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 29 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 773-383-6258

Australian sites

Queensland Children's Hospital, Brisbane, Queensland
Royal Prince Alfred Hospital, Camperdown,
Sydney Children's Hospital, Randwick,
Children's Hospital at Westmead, Westmead,

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

Status
Recruiting
Phase
Phase 3
Sponsor
Harmony Biosciences Management, Inc.
Registry
ClinicalTrials.gov
Start date
28 May 2024
Est. completion
1 July 2026

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇵🇱 Poland 🇷🇴 Romania 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change in severity of EDS as measured by Patient-Reported Outcomes Measurement Information System Bank v1.0 - Sleep-Related Impairment (PROMIS-SRI) T-score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov