- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00174174
Provigil (Modafinil) Study by Taiwan Biotech Co.
September 14, 2005 updated by: National Taiwan University Hospital
A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The change from baseline in the sleep latency.
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yue-Joe Lee, M.D., Department of Psychiatry, National Taiwan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
September 15, 2005
Last Update Submitted That Met QC Criteria
September 14, 2005
Last Verified
October 1, 2004
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Neurologic Manifestations
- Sleep Wake Disorders
- Disorders of Excessive Somnolence
- Sleepiness
- Narcolepsy
- Cataplexy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
Other Study ID Numbers
- 920203l
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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