Provigil (Modafinil) Study by Taiwan Biotech Co.

This study has been completed.

First Received: September 14, 2005 No Changes Posted

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00174174

Purpose

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.

Condition	Intervention
Narcolepsy Cataplexy Sleep Disorders Hypersomnolence Excessive Sleepiness	Drug: Modafinil

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders

Drug Information available for: Modafinil

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

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.

Estimated Enrollment:	30
Study Start Date:	September 2003

Eligibility

Ages Eligible for Study:	12 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174174

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Yue-Joe Lee, M.D.

Department of Psychiatry, National Taiwan University

More Information

No publications provided

Study ID Numbers:	920203l
Study First Received:	September 14, 2005
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00174174 History of Changes
Health Authority:	Taiwan: Department of Health

Study placed in the following topic categories:

Sleep Disorders
Dyssomnias
Central Nervous System Stimulants
Disorders of Excessive Somnolence
Neuroprotective Agents
Modafinil
Sleep Disorders, Intrinsic

Signs and Symptoms
Cataplexy
Narcolepsy
Mental Disorders
Gelineau's Syndrome
Neurologic Manifestations

Additional relevant MeSH terms:

Nervous System Diseases
Physiological Effects of Drugs
Sleep Disorders
Dyssomnias
Central Nervous System Stimulants
Disorders of Excessive Somnolence
Protective Agents
Neuroprotective Agents
Pharmacologic Actions

Modafinil
Sleep Disorders, Intrinsic
Signs and Symptoms
Cataplexy
Narcolepsy
Mental Disorders
Therapeutic Uses
Neurologic Manifestations
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2009