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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

September 14, 2005
May 23, 2012
January 2005
October 2005   (final data collection date for primary outcome measure)
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
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.
Complete list of historical versions of study NCT00214968 on ClinicalTrials.gov Archive Site
  • 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.
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).
Not Provided
Not Provided
 
Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Narcolepsy
Drug: Modafinil
maximum dosage 400 mg/day (4 tablets)
Other Name: Provigil
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
October 2005
October 2005   (final data collection date for primary outcome measure)

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
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00214968
C1538/3034/ES/MN
Not Provided
Teva Pharmaceutical Industries ( Cephalon )
Cephalon
Not Provided
Not Provided
Teva Pharmaceutical Industries
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP