Provigil (Modafinil) Study by Taiwan Biotech Co. - Tabular View

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

September 14, 2005

Start Date ^ICMJE

September 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The change from baseline in the sleep latency.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Provigil (Modafinil) Study by Taiwan Biotech Co.

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Narcolepsy
Cataplexy
Sleep Disorders
Hypersomnolence
Excessive Sleepiness

Intervention ^ICMJE

Drug: Modafinil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00174174

Responsible Party

Study ID Numbers ^ICMJE

920203l

Study Sponsor ^ICMJE

National Taiwan University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Yue-Joe Lee, M.D.

Department of Psychiatry, National Taiwan University

Information Provided By

National Taiwan University Hospital

Verification Date

October 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP