Provigil (Modafinil) Study by Taiwan Biotech Co.

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Modafinil

About this trial

This is an interventional treatment trial for Narcolepsy

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

The change from baseline in the sleep latency.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00174174

First Posted

September 14, 2005

Last Updated

September 14, 2005

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00174174

Brief Title

Provigil (Modafinil) Study by Taiwan Biotech Co.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2004

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Narcolepsy, Cataplexy, Sleep Disorders, Hypersomnolence, Excessive Sleepiness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Modafinil

Primary Outcome Measure Information:

Title

The change from baseline in the sleep latency.

Secondary Outcome Measure Information:

Title

Patient's assessment of general level of daytime sleepiness on ESS.

Title

Patient's cognitive function assessed by psychomotor function test (Trail making test, and Digit Symbol Substitution Test).

Title

Patient's sleep quality evaluated by PSQI.

Title

Safety would be evaluated by tabulating and summarizing all adverse events reported.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yue-Joe Lee, M.D.

Organizational Affiliation

Department of Psychiatry, National Taiwan University

Official's Role

Principal Investigator

Narcolepsy, Cataplexy, Sleep Disorders

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial