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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Teva Pharmaceutical Industries ( Cephalon )

ClinicalTrials.gov Identifier:

NCT00214968

First received: September 14, 2005

Last updated: May 23, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 14, 2005
Last Updated Date	May 23, 2012
Start Date ^ICMJE	January 2005
Primary Completion Date	October 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 23, 2012)	Adverse event evaluations [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ] 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
Original Primary Outcome Measures ^ICMJE (submitted: September 14, 2005)	Evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea/hypopnea syndrome, when administered for up to 6 months.
Change History	Complete list of historical versions of study NCT00214968 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 23, 2012)	Composite Ratings of severity of illness [ Time Frame: up to 6 months ] [ Designated as safety issue: No ] 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) [ Time Frame: up to 6 months ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE (submitted: September 14, 2005)	Evaluate long-term effective by using: the clinical global impression of change (CGI-C) ratings for severity of ES and total score from the Pediatric Daytime Sleepiness Scale (PDSS).
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness
Official Title ^ICMJE	A 6-Month Open Label, Flexible-Dosage Study to Assess the Safety and Effectiveness of PROVIGIL (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Narcolepsy
Intervention ^ICMJE	Drug: Modafinil maximum dosage 400 mg/day (4 tablets) Other Name: Provigil
Study Arm (s)	Experimental: 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 Intervention: Drug: Modafinil
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	92
Completion Date	October 2005
Primary Completion Date	October 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusions Criteria: written informed consent/assent is obtained meet minimal criteria established by the International Classification of Sleep Disorders (ICSD) manual of the American Academy of Sleep Medicine (AASM) for narcolepsy (or presumed narcolepsy) or OSAHS OR have a previous diagnosis of narcolepsy or OSAHS before the screening visit have a complaint of ES are in good health as determined by a medical and psychiatric history, physical examination, ECG, and clinical laboratory tests have blood pressure values greater than those for the 5th percentile and less than the 95th percentile on the National High Blood Pressure Education Program guidelines for blood pressure levels for boys and girls ages 6 to 16 years girls who are postmenarchal or sexually active, have a negative urine pregnancy test at screening, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 2 cycles after participation in the study); acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptives (oral, transdermal, implanted, or injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence able to swallow a tablet similar in size and shape to the study drug tablet negative urine drug screen (UDS) for any illicit drug, alcohol (ethanol), stimulants at screening; if positive for stimulants (prescribed for excessive sleepiness) at screening, UDS to be repeated after a washout period and before baseline have a parent or legal representative who is willing to participate in the study 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
Gender	Both
Ages	6 Years to 16 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00214968
Other Study ID Numbers ^ICMJE	C1538/3034/ES/MN
Has Data Monitoring Committee	Not Provided
Responsible Party	Teva Pharmaceutical Industries ( Cephalon )
Study Sponsor ^ICMJE	Cephalon
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Teva Pharmaceutical Industries
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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