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

National Taiwan University Hospital0 sites30 target enrollmentSeptember 2003

ConditionsNarcolepsy Cataplexy Sleep Disorders Hypersomnolence Excessive Sleepiness

DrugsModafinil

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Narcolepsy
Sponsor: National Taiwan University Hospital
Enrollment: 30
Primary Endpoint: The change from baseline in the sleep latency.
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

National Taiwan University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The change from baseline in the sleep latency.

Secondary Outcomes

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.