Provigil (Modafinil) Study by Taiwan Biotech Co.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00174174 |
Recruitment Status :
Completed
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Narcolepsy Cataplexy Sleep Disorders Hypersomnolence Excessive Sleepiness | Drug: Modafinil | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy |
Study Start Date : | September 2003 |

- The change from baseline in the sleep latency.
- 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.

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Ages Eligible for Study: | 12 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174174
Principal Investigator: | Yue-Joe Lee, M.D. | Department of Psychiatry, National Taiwan University |
ClinicalTrials.gov Identifier: | NCT00174174 |
Other Study ID Numbers: |
920203l |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | September 15, 2005 |
Last Verified: | October 2004 |
Sleep Wake Disorders Narcolepsy Cataplexy Disorders of Excessive Somnolence Sleepiness Nervous System Diseases Neurologic Manifestations Mental Disorders Sleep Disorders, Intrinsic |
Dyssomnias Modafinil Central Nervous System Stimulants Physiological Effects of Drugs Wakefulness-Promoting Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |