Phase 3 Narcolepsy Trial, Recruiting NCT06767683 Sponsor: Alkermes, Inc. Condition: Narcolepsy
Back to Narcolepsy

Phase 3 Narcolepsy Trial, Recruiting

NCT06767683
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:

  • You must have already been eligible for and completed the end-of-treatment visit in one of the qualifying earlier studies of ALKS 2680 (called Vibrance-1, Vibrance-2, or Vibrance-3) for narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia.
  • You must be willing and able to safely stop taking any medications you currently use to manage your sleep disorder symptoms, at least 5 half-lives before the study starts (if you are re-joining) and for the entire length of the study — your doctor must also agree this is safe for you.

Who may not be able to join:

  • You may not be able to join if you have developed a new significant health problem, or have new abnormal heart or lab test results since the earlier study, which the study doctor believes could affect your ability to safely participate.
  • You cannot join if you are currently pregnant, breastfeeding, or planning to become pregnant during the study.
  • You cannot join if you are currently taking part in another clinical trial (other than the qualifying earlier study), or if you have taken an experimental drug or used an experimental device within the last 30 days before screening.

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 28 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

Principal Investigator: Medical Director, Alkermes, Inc.

Phone: 888-235-8008 (US Only)

Australian sites

Alkermes Investigational Site, Sydney, New South Wales
Alkermes Investigational Site, Bedford Park, South Australia
Alkermes Investigational Site, Clayton, Victoria

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
Alkermes, Inc.
Registry
ClinicalTrials.gov
Start date
27 January 2025
Est. completion
1 June 2028

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇿 Czechia 🇫🇷 France 🇮🇹 Italy 🇳🇱 Netherlands 🇪🇸 Spain 🇺🇸 United States

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

Primary endpoints

Incidence of Treatment-Emergent Adverse Events

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: 28 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