Narcolepsy Trial, Recruiting NCT07006233 Sponsor: University of Sydney Condition: Narcolepsy
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Narcolepsy Trial, Recruiting

NCT07006233
Recruiting Not Applicable 🇦🇺 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 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 a specific gene marker called HLA DQB1*06:02.
  • You have a body mass index (BMI) of 18.5 or above (a measure of weight relative to height).
  • You are 18 years old or over.
  • You are willing to make changes to your diet, which may include eating animal products such as meat and dairy.
  • You are willing to regularly check your ketone levels using a finger-prick blood test and urine test strips.
  • Your current everyday diet includes a moderate or high amount of carbohydrates — more than 130g of carbohydrates per day.
  • You are willing to give consent to participate and to follow the study's requirements throughout.
  • You have access to a computer, laptop, tablet, or smartphone with a reliable internet connection.
  • You can read and understand English well enough to read an information sheet on your own, or you have someone who can support you during consultations if needed.

Who may not be able to join:

  • Your BMI is below 18.5, or you have a history of an eating disorder with a score above 3 on a specific eating disorder questionnaire (EDE-Q).
  • You have lost more than 5% of your total body weight in the last 3 months.
  • You have previously had weight-loss (bariatric) surgery, or you are currently taking prescribed weight-loss medication.
  • You have been diagnosed with an unstable psychiatric (mental health) condition, not including anxiety or depression.
  • You have a cognitive (thinking or memory) impairment that would make it difficult to understand the study or give informed consent.
  • You have a physical impairment that would prevent you from meeting the study's requirements.
  • You are not able to read or understand English, and cannot read the participant information sheet.
  • You do not have reliable internet access or a suitable device to take part in online video consultations and complete questionnaires.
  • You are currently breastfeeding, pregnant, or could become pregnant and are not willing to avoid pregnancy during the study.
  • Your current everyday diet is already low in carbohydrates or ketogenic — meaning you eat fewer than 130g of carbohydrates per day.
  • Your current diet excludes all animal products (for example, if you follow a vegan diet).
  • Your blood test results suggest another possible cause for your excessive sleepiness, as judged by the study doctor (confirm with trial site).
  • You have changed your medication or dosage within the last 4 weeks.
  • You have an inherited metabolic disorder, a history of dangerously low blood sugar (hypoglycaemia), or a condition called insulinoma.
  • You have Type 1 or Type 2 diabetes and require insulin injections.
  • You have uncontrolled medical conditions or significant health problems that the study doctor believes could put you at risk from the dietary changes involved in this study (confirm with trial site).
  • You currently have a cancer diagnosis, not including certain skin cancers or non-harmful (benign) cancers.
  • You are currently enrolled in another clinical trial involving a drug or medical intervention, or you have received an experimental drug within the last 12 weeks.

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Elizabeth A Machan, PhD, University of Sydney

Phone: +61408 290 687

Australian sites

Woolcock Institute of Medical Research, Macquarie Park, New South Wales
+61 2 9805 3293

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
Not Applicable
Sponsor
University of Sydney
Registry
ClinicalTrials.gov
Start date
23 June 2025
Est. completion
1 June 2026

Where this trial is recruiting

🇦🇺 Australia

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

Primary endpoints

Feasibility - using quantitative measures of feasibility; Feasibility - using quantitative measures of tolerability; Feasibility - using quantitative measures of compliance

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