Provigil (Modafinil) Study by Taiwan Biotech Co.

Not Applicable

Completed

• Conditions: Narcolepsy; Cataplexy; Sleep Disorders; Hypersomnolence; Excessive Sleepiness

• Registration Number: NCT00174174
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Status Verified: 2004-10
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Last Update Submitted: 2005-09-14
• Study First Posted: 2005-09-15
• Last Update Posted: 2005-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The change from baseline in the sleep latency.

Secondary Outcome Measures

Name	Time	Method
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.