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

Phase 3

Completed

• Conditions: Narcolepsy
• Interventions: Drug: Modafinil

• Registration Number: NCT00214968
• Lead Sponsor: Cephalon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2012-05
• Disposition First Submitted: 2012-05-23
• Disposition First Submitted QC: 2012-05-23
• Last Update Submitted: 2012-05-23
• Disposition First Posted: 2012-05-31
• Last Update Posted: 2012-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

• have self-induced sleep deprivation/poor sleep hygiene
• have a past or present seizure disorder (except history of single febrile seizure), a history of psychosis, or of clinically significant head trauma (eg, brain damage) or past neurosurgery
• have a history of suicide attempt, or are at suicidal risk
• a clinically significant drug sensitivity to stimulants such as amfetamine, dexamfetamine, or methylphenidate; and/or modafinil or any of its components
• use of any monoamine oxidase (MAO) inhibitors or selective serotonin reuptake inhibitors (SSRIs) within 2 weeks of the baseline visit (NOTE: SSRIs will be allowed for cataplexy if the patient has been on a stable dose for at least 1 month.)
• received any investigational drug (except modafinil) within 4 weeks of the baseline visit
• any disorder that could interfere with drug absorption, distribution, metabolism, or excretion (including previous gastrointestinal surgery)
• active, clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other major clinically significant disorder/disease
• any clinically significant deviation from the normal range(s) in the physical examination or ECG findings, or clinical laboratory test results (ie, serum chemistry, hematology) at the screening or baseline visit
• absolute neutrophil count (ANC) below the lower limit of normal at screening (NOTE: If the ANC is below the lower limit of normal at the baseline visit, the medical monitor will be consulted for continued eligibility in the study.)
• a history of alcohol, narcotic, or any other substance abuse
• pregnant or lactating/nursing girl

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modafinil	Modafinil	Subjects began taking Provigil at a dosage of 100 mg/day (1 tablet) and increased their dosage by 100 mg/day each week for up to 4 weeks

Primary Outcome Measures

Name	Time	Method
Adverse event evaluations	up to 6 months	Evaluate the safety and tolerability of treatment in children and adolescents with excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea/hypopnea syndrome, when administered for up to 6 months

Secondary Outcome Measures

Name	Time	Method
Composite Ratings of severity of illness	up to 6 months	Clinical global impression (CGI-C) ratings for severity of illness. The ratings range from 1 to 7; 1 =normal-not at all ill to 7 =among the most extremely ill.
Total score from the Pediatric Daytime Sleepiness Scale (PDSS)	up to 6 months	A measure of daytime sleepiness and school-related outcomes using PDSS questions: This self-report 8-item questionnaire asks questions with ranges from Always to Never; always being the worst case and never the best case.