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Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness

NCT00214968 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2012-05-31

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or obstructive sleep apnea/hypopnea syndrome (OSAHS), when administered for up to 6 months.

Conditions

Interventions

DRUG

Modafinil

maximum dosage 400 mg/day (4 tablets)

Sponsors & Collaborators

  • Cephalon

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2005-10-31
Completion
2005-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00214968 on ClinicalTrials.gov