Provigil (Modafinil) Study by Taiwan Biotech Co.

Sleep Disorders Clinical Trial

Official title:

A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174174
• Other study ID #: 920203l
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: September 14, 2005
• Start date: September 2003

Study information

• Verified date: October 2004
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataplexy
• Excessive Sleepiness
• Hypersomnolence
• Narcolepsy
• Parasomnias
• Sleep Disorders

Intervention

Drug:
• Modafinil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in the sleep latency.
Secondary	Patient's assessment of general level of daytime sleepiness on ESS.
Secondary	Patient's cognitive function assessed by psychomotor function test (Trail making test, and Digit Symbol Substitution Test).
Secondary	Patient's sleep quality evaluated by PSQI.
Secondary	Safety would be evaluated by tabulating and summarizing all adverse events reported.