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Provigil (Modafinil) Study by Taiwan Biotech Co.
This study has been completed.
Sponsor:
National Taiwan University Hospital
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00174174
First received: September 14, 2005
Last updated: NA
Last verified: October 2004
History: No changes posted
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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: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy |
Resource links provided by NLM:
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 (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00174174
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
| ClinicalTrials.gov Identifier: | NCT00174174 History of Changes |
| Other Study ID Numbers: |
920203l |
| Study First Received: | September 14, 2005 |
| Last Updated: | September 14, 2005 |
Additional relevant MeSH terms:
|
Sleep Wake Disorders Parasomnias Narcolepsy Cataplexy Disorders of Excessive Somnolence Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Sleep Disorders, Intrinsic |
Dyssomnias Modafinil Armodafinil Wakefulness-Promoting Agents Central Nervous System Stimulants Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017