Provigil (Modafinil) Study by Taiwan Biotech Co.
Information source: National Taiwan University Hospital
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Narcolepsy; Cataplexy; Sleep Disorders; Hypersomnolence; Excessive Sleepiness
Intervention: Modafinil (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s):
Yue-Joe Lee, M.D., Principal Investigator, Affiliation: Department of Psychiatry, National Taiwan University
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.
Clinical Details
Official title: A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: The change from baseline in the sleep latency.
Secondary outcome: 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.
Eligibility
Minimum age: 12 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: September 2003
Last updated: September 14, 2005
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