CompletedNot Applicable

Provigil (Modafinil) Study by Taiwan Biotech Co.

30 participantsStarted 2003-09

Plain-language summary

The primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness associated with narcolepsy. Both of the subjective and objective sleepiness of the patients were assessed in the experiment by repeat measures.

Who can participate

Age range

12 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Polysomnographic findings of shortened sleep latency less than 5 minutes average of Multiple Sleep Latency Test, and two or more SOREM should be fulfilled. * Age of 12 y/o to 55 y/o. * The liver and kidney functions are within normal limits. * Meeting the strict criteria of narcolepsy described above. * Wash out any medications which might enhance wakefulness or affect nocturnal sleep two weeks prior to the experiments. * Willingness to comply with the protocol and signed the written Informed Consent. Exclusion Criteria: * Patients whose hypersomnia was caused by severely sleep deprived, phase delayed, or suspected long sleeper. * Patients with concomitant neurological disorder and psychiatric disorders. * Patients with sleep-related breathing disorders whose apnea/hypopnea index (AHI) was 5 pauses per hour above. * Patients with Restless Leg Syndrome \& Periodic Limbs Movements whose index was more than 5 per hour. * Patients who are pregnant or breast-feeding.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The change from baseline in the sleep latency.

Trial details

NCT IDNCT00174174

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Narcolepsy trials

Who can participate

Age range

12 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.