Narcolepsy
Plain English clinical trial information, updated daily from ClinicalTrials.gov and public government registries. Not medical advice.
How these figures are counted
- Trials on record is every trial tagged to this condition at any stage, except those withdrawn before starting or terminated early. Most are completed rather than ongoing, so this is a measure of research history, not of current activity. It is also smaller than the sitewide "trials tracked" figure, which does include withdrawn and terminated trials.
- Recruiting now counts only trials whose registry status is "Recruiting". Trials listed as not yet recruiting or enrolling by invitation are excluded, so this understates how many may open to new participants soon.
- Australian sites counts trials counted under "Recruiting now" that list at least one Australian site. A site being listed does not mean it is currently enrolling, and Australian trials registered only on ANZCTR are not counted yet, so this understates local availability.
- Phase 3 trials counts trials counted under "Recruiting now" that are at Phase 3.
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Understanding Narcolepsy
Narcolepsy is a long-term neurological condition that affects the brain's ability to control sleep and wakefulness. People with narcolepsy often feel overwhelming and sudden urges to sleep during the day, even after a full night's rest. Some people also experience a sudden loss of muscle control triggered by strong emotions like laughter or surprise — this is called cataplexy. The condition happens because the brain doesn't produce enough of a chemical called orexin (sometimes called hypocretin), which helps keep us awake and alert. It is a chronic condition, meaning it doesn't go away, but it can be managed.
Narcolepsy is more common than many people realise. In Australia, it is estimated to affect around 1 in 2,000 people, though many cases go undiagnosed or are mistaken for other conditions for years. It can appear at any age, but symptoms often first show up in teenagers or young adults. Both males and females are affected, and it occurs across all backgrounds and walks of life. Getting a diagnosis can sometimes take time, so reaching a confirmed diagnosis is actually an important step forward.
Once diagnosed, people in Australia are typically referred to a sleep specialist or neurologist who has experience with the condition. Management usually involves a combination of approaches, including lifestyle adjustments like planned short naps, regular sleep schedules, and changes to daily routines. Medications are also commonly discussed as part of managing symptoms such as daytime sleepiness and cataplexy. Support from healthcare professionals, as well as connecting with organisations like Narcolepsy Australia, can help people and their families better understand what to expect and how to cope day to day.
This overview is an AI generated summary written from public medical sources and checked on a sample basis. It is general information, not medical advice or a diagnosis. Always speak with your doctor about your situation. How we use AI
Can you access treatment for Narcolepsy in Australia right now? Here's what's publicly known.
- 4 PBS-subsidised medicines are mapped to Narcolepsy on the Pharmaceutical Benefits Scheme, listed below. Your doctor can advise whether a PBS-subsidised option is appropriate for you.
- 5 clinical trials currently recruiting at Australian sites for Narcolepsy.
Information on this site does not constitute medical advice. Data is sourced from publicly available government registries. Always consult your doctor before making any health decisions. Trial status should be verified directly with the trial site.
PBS-subsidised medicines for Narcolepsy
4 medicines listed on the PBS for Narcolepsy. Filter by authority type, or open the full table below.
Full PBS medicines table 4 listed
These medicines are listed on the Pharmaceutical Benefits Scheme (PBS) for the specific indications shown. A listing does not mean a medicine is right for you; your doctor decides what is appropriate. Prices shown are the PBS-determined dispensed price. Most patients pay only the standard co-payment, up to AU$25.00 per script (general) or AU$7.70 (concession or Safety Net) in 2026, with the Australian Government subsidising the rest.
| Medicine | Brand(s) | Listed for | ||
|---|---|---|---|---|
| Armodafinil | Nuvigil | Narcolepsy | AU$41.9 | |
| Dexamfetamine | Aspen Pharmacare Australia Pty Ltd | Narcolepsy | AU$5.95 | |
| Modafinil | Modafin | Narcolepsy | AU$48.37 | |
| Clomipramine | APO-Clomipramine | Cataplexy | AU$4.65 | Restricted benefit |
Source: Pharmaceutical Benefits Scheme (PBS), © Commonwealth of Australia. Data used and redistributed under permission; not modified from its original wording where displayed verbatim.
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Become a founding memberResearch pipeline
Where trials for Narcolepsy currently sit in the development pipeline. The funnel shape shows how few drugs reach later phases in general; the counts are this condition's actual trial numbers.
Most active research sponsors
Organisations with the most recruiting trials for Narcolepsy.
Where trials are running
Clinical trial sites for Narcolepsy by country. Australia is highlighted.
Clinical trials for Narcolepsy
Showing 36 of 36 trials
The plain English eligibility text on each trial below is an AI generated summary of the official criteria, checked on a sample basis. How we use AI
🇦🇺 NCT00228553 · Cephalon Phase 3 · 7 countries
**Who might be able to join this trial:** - Adults aged 18 to 65 (men or women of any ethnic background) who are seen as outpatients. - People who have already completed one of four specific Cephalon-sponsored clinical trials and have been recommended by their doctor to continue into this study. - People with sleep apn...
🇦🇺 NCT02720744 · Avadel Phase 3 · 6 countries
**Who might be able to join this trial:** - You are 16 years of age or older (if you are 16 or 17, a parent or legal guardian must also give their permission) - You are willing and able to sign a consent form agreeing to take part in the study - You have been officially diagnosed with Type 1 or Type 2 narcolepsy, conf...
🇦🇺 NCT05687903 · Takeda Phase 2 · 12 countries
**Who might be able to join this trial:** - You are between 18 and 70 years old when you sign up (in Japan, ages 16 to 70 may also be eligible). - Your Body Mass Index (BMI) — a measure of body weight relative to height — is between 18 and 40. - You have been officially diagnosed with Narcolepsy Type 1 based on specifi...
🇦🇺 NCT05687916 · Takeda Phase 2 · 12 countries
**Who might be able to join this trial:** - You are between 18 and 70 years old at the time of signing the consent form (in Japan, ages 16 to 70 may be included). - You have been officially diagnosed with Type 2 Narcolepsy (narcolepsy without cataplexy), confirmed by specific sleep studies (overnight sleep test and day...
🇦🇺 NCT06505031 · Takeda Phase 3 · 11 countries
**Who might be able to join this trial:** - Your body mass index (BMI) — a measure of body weight relative to height — falls between 18 and 40. - You have been officially diagnosed with Narcolepsy Type 1 (a sleep disorder that causes extreme daytime sleepiness and sudden muscle weakness) according to recognised medical...
🇦🇺 NCT05816382 · Takeda Phase 3 · 12 countries
**Who might be able to join this trial:** - You have been diagnosed with Narcolepsy Type 1 (a sleep disorder causing excessive daytime sleepiness and muscle weakness triggered by emotions) and have already completed a controlled study using the drug TAK-861 - Your doctor who is overseeing the study has no medical conce...
🇦🇺 NCT06767683 · Alkermes, Inc. Phase 3 · 8 countries
**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...
🇦🇺 NCT07006233 · University of Sydney Not Applicable · 1 country
**Who might be able to join this trial:** - You have been diagnosed with narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia (a condition causing excessive sleepiness), confirmed by sleep testing that meets recognised diagnostic standards. - If you have narcolepsy type 1, you must have tested positive for...
🇦🇺 NCT07455383 · Alkermes, Inc. Phase 3 · 4 countries
**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 me...
🇦🇺 NCT07633301 · Takeda Phase 2 · 7 countries
**Who might be able to join this trial:** - Your body mass index (BMI — a measure of weight relative to height) is between 18 and 40 (inclusive). - You have been officially diagnosed with Narcolepsy Type 1 (a sleep disorder that causes extreme daytime sleepiness and sudden muscle weakness) according to recognised medic...
NCT04899947 · Jazz Pharmaceuticals Not Applicable · 1 country
Who might be able to join this trial: - The participant must be a child or teenager (under 18 years old) who has been officially diagnosed with narcolepsy by a doctor - The participant must be under 18 years of age - The participant (and/or their parent or guardian) must be willing to take part in the registry and sign...
NCT05536011 · Harmony Biosciences Management, Inc. Not Applicable · 1 country
**Who might be able to join this trial:** - You are pregnant, regardless of your age - You agree to take part in the study - You agree to allow your healthcare provider(s) to share your medical information with the registry - If you have been diagnosed with narcolepsy: you have taken at least one dose of pitolisant or...
NCT05773872 · Centre Hospitalier Universitaire, Amiens Not Applicable · 1 country
Who might be able to join this trial: - You are 18 years old or older - You have been diagnosed with narcolepsy (type 1 or type 2) or a condition called idiopathic hypersomnia (a sleep disorder causing excessive daytime sleepiness) - You do not object to taking part in the study Who may not be able to join: - You have...
NCT06279247 · Qilu Hospital of Shandong University Not Applicable · 1 country
**Who might be able to join this trial:** - You may be eligible if you have been diagnosed with a sleep disorder according to the standard international guidelines for diagnosing sleep conditions (called ICSD-3). **Who may not be able to join:** - People whose excessive sleepiness is caused by shift work, not getting...
NCT06292598 · Centre Hospitalier Universitaire de Nīmes Not Applicable · 1 country
**Who might be able to join this trial:** - You have been diagnosed with type 1 narcolepsy (a sleep disorder that causes sudden muscle weakness and excessive sleepiness). - You are either not yet being treated for narcolepsy (for the newly diagnosed group) or are already being monitored for narcolepsy over time (for th...
NCT06336057 · University Hospital, Toulouse Not Applicable · 1 country
**Who might be able to join this trial:** *For people with narcolepsy (main study group):* - You are an adult who has been diagnosed with Type 1 narcolepsy based on recognised medical guidelines and have completed a 48-hour sleep study at a Sleep Laboratory - You are part of a social security system (such as having he...
NCT06383806 · University of Utah Not Applicable · 1 country
**Who might be able to join this trial:** *For people with narcolepsy:* - People who have been diagnosed with narcolepsy type 1 or narcolepsy type 2 - People who experience nightmares at least once a week - People aged 18 or older - People who can speak, read, and write in English - People who live in the United State...
NCT06413420 · Axsome Therapeutics, Inc. Not Applicable · 1 country
**Who might be able to join this trial:** - You are pregnant, regardless of your age - You have been diagnosed with narcolepsy or obstructive sleep apnea (a sleep disorder where breathing stops and starts during sleep), OR you have taken solriamfetol or other medications used to promote wakefulness or stimulants at any...
NCT06457945 · Hospices Civils de Lyon Not Applicable · 1 country
**Who might be able to join this trial:** - You have been diagnosed with Narcolepsy Type 1 (NT1) or Idiopathic Hypersomnia (IH) based on recognised international sleep disorder guidelines - If you have Idiopathic Hypersomnia, you have had a specific sleep test (MSLT) that showed you fall asleep unusually quickly (confi...
NCT06484348 · Hospices Civils de Lyon Not Applicable · 1 country
Who might be able to join this trial: - People diagnosed with Narcolepsy Type 1 or Idiopathic Hypersomnia (a condition causing excessive daytime sleepiness), or healthy people who do not have any sleep disorders - People who are comfortable using a smartphone on a regular basis Who may not be able to join: - People wh...
NCT06752668 · Centessa Pharmaceuticals (UK) Limited Phase 2 · 5 countries
Who might be able to join this trial: - You are between 18 and 65 years old - Your body mass index (a measure of body weight relative to height) is between 17 and 37 - You have been diagnosed with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia (a sleep disorder causing excessive daytime sleepiness) bas...
NCT06797284 · Second Affiliated Hospital of Soochow University Not Applicable · 1 country
**Who might be able to join this trial:** - You have been clearly diagnosed by a specialist with insomnia, narcolepsy, or RBD (a sleep disorder where people act out their dreams during sleep) and are willing to sign a consent form to participate. **Who may not be able to join:** - You have a major brain or nervous sys...
NCT06809803 · Stanford University Phase 2 · 1 country
Who might be able to join this trial: - You must be a patient currently receiving care at the Stanford Sleep Clinic. - You must have an official diagnosis of narcolepsy type 1, confirmed by excessive daytime sleepiness plus at least one of the following: a specific spinal fluid test result, a history of sudden temporar...
NCT06952699 · Takeda Phase 2 · 7 countries
**Who might be able to join this trial:** - You weigh at least 40 kilograms (about 88 pounds) and your body mass index (BMI) is between 16 and 38. - You have been officially diagnosed with Narcolepsy Type 2 (NT2). **Who may not be able to join:** - You have another medical condition (besides NT2) that causes excessive...
NCT07096674 · Centessa Pharmaceuticals (UK) Limited Phase 2 · 4 countries
Who might be able to join this trial: - You have been diagnosed with narcolepsy (type 1 or type 2) or a condition called idiopathic hypersomnia (a sleep disorder causing excessive daytime sleepiness), and you previously qualified for and completed the full treatment period in a related earlier study called CRYSTAL-1 (s...
NCT07299097 · Takeda Not Applicable · 1 country
**Who might be able to join this trial:** **Core Group:** - You have been diagnosed with Narcolepsy Type 1 or Type 2 (a sleep disorder causing excessive daytime sleepiness) according to recognised medical guidelines, and you were alive at any point during 2023 or 2024. - You can be any age, ethnicity, or nationality....
NCT07363720 · Takeda Phase 3 · 7 countries
**Who might be able to join this trial:** - Your body weight is in a healthy range for your height, with a BMI (body mass index) between 18 and 40. - You have been officially diagnosed with Narcolepsy Type 1 (a sleep disorder that causes extreme daytime sleepiness and sudden muscle weakness) using recognised medical gu...
NCT07365566 · University Hospital, Toulouse Not Applicable · 1 country
**Who might be able to join this trial:** *Main participant group:* - You have been diagnosed with a sleep condition called iRBD (a disorder where you act out your dreams during sleep), confirmed by an overnight sleep study - You have not been diagnosed with Parkinson's disease or any other brain-degenerating conditio...
NCT07493265 · Eisai Inc. Phase 2 · 10 countries
**Who might be able to join this trial:** - Adults aged 18 or older at the time of giving consent to participate - People in the Narcolepsy Type 1 (NT1) group must have been diagnosed with NT1 within the last 10 years, confirmed by specific sleep study results and medical history, or by a spinal fluid test showing ver...
NCT07502443 · Alkermes, Inc. Phase 3 · 2 countries
**Who might be able to join this trial:** - You are willing and able to follow all study rules, including lifestyle guidelines, using birth control as directed, wearing a sleep-tracking device, keeping a diary, and (if you already use a treatment for sleep apnea) continuing to use it consistently for 30 days before the...
NCT07540897 · Alkermes, Inc. Phase 3 · 1 country
**Who might be able to join this trial:** - You have been diagnosed with Narcolepsy Type 1 (a sleep condition involving excessive daytime sleepiness and sudden muscle weakness), confirmed by specific sleep tests or a spinal fluid test showing low levels of a brain chemical called hypocretin-1 **Who may not be able to...
NCT07584434 · Vertex Pharmaceuticals Incorporated Phase 1 · 1 country
Who might be able to join this trial: - Your Body Mass Index (BMI) — a measure of body weight relative to height — must be between 18.0 and 30.0 - You must weigh more than 50 kilograms (about 110 pounds) - You must be a non-smoker, or must have stopped smoking at least 3 months before your screening appointment, confir...
NCT07598708 · Centessa Pharmaceuticals (UK) Limited Phase 3 · 1 country
Who might be able to join this trial: - You are between 18 and 70 years old - Your Body Mass Index (BMI) is between 17.0 and 45 (a measure of body weight relative to height) - You have been diagnosed with Narcolepsy Type 1 or Type 2 according to recognized sleep disorder guidelines - You are willing and able to stop ta...
NCT07613710 · H. Lundbeck A/S Phase 1 · 1 country
**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 w...
NCT07646678 · Takeda Phase 3 · 1 country
Who might be able to join this trial: - You are willing and able to understand and follow all the steps and requirements of the trial. - You have been diagnosed with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH), and you have already completed the treatment period in a related previou...
NCT07675135 · Harmony Biosciences Management, Inc. Phase 3 · 1 country
**Who might be able to join this trial:** - You have been officially diagnosed with Type 1 or Type 2 Narcolepsy (based on a standard sleep disorder classification system) within the last 10 years. - You experience excessive daytime sleepiness. - If you are already taking certain regular medications or supplements (incl...
Advocacy and support in Australia
Organisations that can offer information, support, or connection for Narcolepsy. Where more than one is listed, they serve different needs or regions, so choose whichever fits your situation.
NODSS, the Narcolepsy and Overwhelming Daytime Sleep Society of Australia, provides peer support for narcolepsy and related conditions. The Sleep Health Foundation provides broader education and advocacy on sleep health.
This is a starting point, not medical advice or an endorsement. Contact details change; search the organisation name to find its current website.