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Provigil (Modafinil) Study by Taiwan Biotech Co.

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ClinicalTrials.gov Identifier: NCT00174174
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Narcolepsy Cataplexy Sleep Disorders Hypersomnolence Excessive Sleepiness Drug: Modafinil Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Modafinil

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The change from baseline in the sleep latency.

Secondary Outcome Measures :
  1. Patient's assessment of general level of daytime sleepiness on ESS.
  2. Patient's cognitive function assessed by psychomotor function test (Trail making test, and Digit Symbol Substitution Test).
  3. Patient's sleep quality evaluated by PSQI.
  4. Safety would be evaluated by tabulating and summarizing all adverse events reported.

Eligibility Criteria
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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
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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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


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Yue-Joe Lee, M.D. Department of Psychiatry, National Taiwan University
More Information
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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
Additional relevant MeSH terms:
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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