Phase 3 Narcolepsy Trial, Recruiting (NCT07455383)

Phase 3 Narcolepsy Trial, Recruiting NCT07455383 Sponsor: Alkermes, Inc. Condition: Narcolepsy

Printed from Voxsanity (voxsanity.com.au) — NCT07455383 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Narcolepsy

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 have been diagnosed with Type 1 Narcolepsy (a sleep disorder involving excessive daytime sleepiness and sudden muscle weakness) based on established medical guidelines, confirmed by either a sleep study (overnight sleep test and daytime nap test) or a spinal fluid test measuring a specific brain chemical.

Who may not be able to join:

You have another sleep disorder or condition that affects how you sleep or stay awake.
You have, or have a history of, another significant health condition, illness, or have had a surgical procedure that the trial doctor believes could affect your safety, interfere with the study results, or make it hard for you to complete the trial.
You are currently taking part in another clinical trial, have taken an experimental drug, or used an experimental medical device within the last 30 days before your first visit — or you have previously taken part in a specific related study called ALKS 2680-201.
You are currently pregnant, breastfeeding, or are planning to become pregnant during the course of the trial.

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, MD, Alkermes, Inc.

Phone: 888-235-8008 (US Only)

Australian sites

Alkermes Investigational Site, Macquarie Park, New South Wales

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07455383

Sponsor: Alkermes, Inc.

Phase: Phase 3

Status: Recruiting

Condition: Narcolepsy

Trial contact: 888-235-8008 (US Only)

More information: https://clinicaltrials.gov/study/NCT07455383

Eligibility summary (AI generated)

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have been diagnosed with Type 1 Narcolepsy (a sleep disorder involving excessive daytime sleepiness and sudden muscle weakness) based on established medical guidelines, confirmed by either a sleep study (overnight sleep test and daytime nap test) or a spinal fluid test measuring a specific brain chemical.

Who may not be able to join:

You have another sleep disorder or condition that affects how you sleep or stay awake.
You have, or have a history of, another significant health condition, illness, or have had a surgical procedure that the trial doctor believes could affect your safety, interfere with the study results, or make it hard for you to complete the trial.
You are currently taking part in another clinical trial, have taken an experimental drug, or used an experimental medical device within the last 30 days before your first visit — or you have previously taken part in a specific related study called ALKS 2680-201.
You are currently pregnant, breastfeeding, or are planning to become pregnant during the course of the trial.

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 3

Sponsor

Alkermes, Inc.

Registry

ClinicalTrials.gov

Start date

6 April 2026

Est. completion

1 May 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇳🇱 Netherlands 🇺🇸 United States

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

Primary endpoints

Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level

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