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Completed

NCT Number: NCT00174174

Provigil (Modafinil) Study by Taiwan Biotech Co.

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.

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Key information

Conditions

Narcolepsy Cataplexy Disorders of Excessive Somnolence Dyssomnias Excessive Sleepiness Hypersomnolence Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modafinil

Drug

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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy

Important dates

Study start
2003
First posted
Sep 15, 2005
Registry last updated
Sep 15, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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