Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial enrolled 743 people who were taking armodafinil (at doses of 100 to 250 mg per day) for one of three sleep-related conditions: narcolepsy (a condition causing sudden, uncontrollable sleepiness), obstructive sleep apnoea/hypopnoea syndrome (where breathing repeatedly stops during sleep), or shift work sleep disorder (disrupted sleep caused by working non-standard hours). The trial ran for up to two years and had a single group — there was no comparison or placebo group reported. Of the 743 people who started, 313 completed the trial and 430 did not complete it. The reported data shows that the primary outcome the trial was measuring was safety and tolerability — in other words, what unwanted medical events (called "adverse events") occurred in participants over time. Researchers tracked both serious adverse events (those leading to outcomes such as death, hospitalisation, or significant disability) and non-serious adverse events. According to the results reported on ClinicalTrials.gov, 667 out of the 743 participants experienced at least one adverse event of any kind. The data as submitted does not provide a further breakdown of how many of these were serious versus non-serious, so those figures cannot be described here. It is worth noting that no secondary outcome measure data appears to have been included in the submitted results. The reported data shows only the single primary safety measure described above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Narcolepsy Trial, Completed
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:
- 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 apnea (OSAHS) who regularly use a CPAP breathing machine, which their doctor considers to still be working effectively.
- People with shift work sleep disorder who work at least 5 night shifts per month, where each shift includes at least 6 hours between 10pm and 8am and is no longer than 12 hours.
- People who are considered to be in generally good health.
- Women who are either surgically unable to have children, have been through menopause for at least 2 years, or are using an accepted form of birth control (such as barrier methods with spermicide, hormonal contraceptives used alongside a barrier method, or an IUD).
- People who are willing and able to follow the study rules and attend all required clinic appointments.
Who may not be able to join:
- People who have any significant uncontrolled health condition, whether treated or untreated.
- People who have been diagnosed with another sleep disorder beyond the main conditions this study covers (narcolepsy, sleep apnea, or shift work sleep disorder).
- People who consume more than 600mg of caffeine per day on average (from coffee, tea, or other caffeine-containing food or drinks).
- People who are taking prescription medications not permitted by the study, or who have significantly used over-the-counter medicines within 7 days before the first visit.
- People with a history of alcohol, drug, or narcotic misuse as defined by standard psychiatric guidelines.
- People who test positive on a urine drug screening test (confirm with trial site for timing details around this).
- People who have a significant abnormality found during a physical examination.
- Women who are pregnant or breastfeeding; any woman who becomes pregnant during the study would need to leave it.
- People who have any condition that may affect how the body absorbs, processes, or removes medication, including certain gastrointestinal surgeries.
- People who have a known significant sensitivity or allergic reaction to stimulant medications.
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.
Contact this trial
Principal Investigator: Sponsor's Medical Director, MD, Cephalon
Australian sites
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
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)
Can't join this trial?
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.