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Provigil (Modafinil) Study by Taiwan Biotech Co.

This study has been completed.
Information provided by:
National Taiwan University Hospital Identifier:
First received: September 14, 2005
Last updated: NA
Last verified: October 2004
History: No changes posted
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.

Condition Intervention
Narcolepsy Cataplexy Sleep Disorders Hypersomnolence Excessive Sleepiness Drug: Modafinil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The change from baseline in the sleep latency.

Secondary Outcome Measures:
  • Patient's assessment of general level of daytime sleepiness on ESS.
  • Patient's cognitive function assessed by psychomotor function test (Trail making test, and Digit Symbol Substitution Test).
  • Patient's sleep quality evaluated by PSQI.
  • Safety would be evaluated by tabulating and summarizing all adverse events reported.

Estimated Enrollment: 30
Study Start Date: September 2003

Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00174174

Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Yue-Joe Lee, M.D. Department of Psychiatry, National Taiwan University
  More Information Identifier: NCT00174174     History of Changes
Other Study ID Numbers: 920203l
Study First Received: September 14, 2005
Last Updated: September 14, 2005

Additional relevant MeSH terms:
Sleep Wake Disorders
Disorders of Excessive Somnolence
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Sleep Disorders, Intrinsic
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on September 21, 2017