Provigil (Modafinil) Study by Taiwan Biotech Co.

This study has been completed.
Sponsor:
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
  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
Endpoint Classification: Safety/Efficacy Study
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
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

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

Additional relevant MeSH terms:
Narcolepsy
Cataplexy
Sleep Disorders
Parasomnias
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014