Provigil (Modafinil) Study by Taiwan Biotech Co.

September 14, 2005 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The change from baseline in the sleep latency.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Yue-Joe Lee, M.D., Department of Psychiatry, National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2005

Last Update Submitted That Met QC Criteria

September 14, 2005

Last Verified

October 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 920203l

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe