Provigil (Modafinil) Study by Taiwan Biotech Co.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Brief Summary

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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

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Conditions

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Narcolepsy Cataplexy Sleep Disorders Hypersomnolence Excessive Sleepiness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Modafinil

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Yue-Joe Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, National Taiwan University

Other Identifiers

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920203l

Identifier Type: -

Identifier Source: org_study_id