ClinicalTrials.gg
CompletedNCT00174174Updated Sep 15, 2005

Provigil (Modafinil) Study by Taiwan Biotech Co.

An interventional study of Modafinil in Narcolepsy, Cataplexy and Sleep Disorders, sponsored by National Taiwan University Hospital. Completed. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2005-09-15.

Primary conditionCataplexyRegistry: NarcolepsyReclassifiedWhy we changed it
Registry
Narcolepsy — the first condition term the registry derived for this study.
ClinicalTrials.gg
Cataplexy
Why
  1. The study's listed conditions name Cataplexy, a narrower term within Narcolepsy.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
12 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Narcolepsy
  • Cataplexy
  • Sleep Disorders
  • Hypersomnolence
  • Excessive Sleepiness

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03

In context

Cataplexy Reclassified

31 studies on the registry are indexed under Cataplexy; 5 are open to participants now.

This study's enrollment of 30 is below the median of 117 across 27 interventional studies indexed under Cataplexy.

Browse Cataplexy studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Compared within Cataplexy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Narcolepsy. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
30 participants

Interventions

06

What researchers measure

Primary outcomes

  1. The change from baseline in the sleep latency.

Secondary outcomes

  1. Patient's assessment of general level of daytime sleepiness on ESS.

  2. Patient's cognitive function assessed by psychomotor function test (Trail making test, and Digit Symbol Substitution Test).

  3. Patient's sleep quality evaluated by PSQI.

  4. Safety would be evaluated by tabulating and summarizing all adverse events reported.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00174174
First posted
Sep 15, 2005
Start date
Sep 2003
Last update
Sep 15, 2005

Study contacts

Yue-Joe Lee, M.D.
principal investigator · Department of Psychiatry, National Taiwan University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2004. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Modafinil

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