NCT00174174

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 15, 2005

Status Verified

October 1, 2004

First QC Date

September 14, 2005

Last Update Submit

September 14, 2005

Conditions

NarcolepsyCataplexySleep DisordersHypersomnolenceExcessive Sleepiness

Outcome Measures

Primary Outcomes (1)

  • The change from baseline in the sleep latency.

Secondary Outcomes (4)

  • 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.

Interventions

ModafinilDRUG

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NarcolepsyCataplexySleep Wake DisordersDisorders of Excessive Somnolence

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Yue-Joe Lee, M.D.

    Department of Psychiatry, National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 15, 2005

Study Start

September 1, 2003

Last Updated

September 15, 2005

Record last verified: 2004-10