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Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness
This study has been completed.
First Received: September 14, 2005   Last Updated: April 20, 2006   History of Changes
Sponsor: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00214968
  Purpose

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.


Condition Intervention Phase
Excessive Daytime Sleepiness
Narcolepsy
Drug: PROVIGIL (modafinil)
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cephalon:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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).

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 postmenarche 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: Patients are excluded for participating in this if 1 or more of the following criteria are met:

  • 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 atleast 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.)
  • seated pulse outside the range of 60 to 115 bpm after resting for 5 minutes
  • a history of alcohol, narcotic, or any other substance abuse or dependence as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM-IV) criteria
  • a total daily intake of more than 500mg of caffeine per day (eg, approximately ten 330-ml cans of caffeinated soft drinks, 5 cups of coffee or tea, or about 750g of chocolate per day) within 1 week of the baseline visit
  • pregnant or lactating/nursing girl; any girl who becomes pregnant during the study will be withdrawn
  • a clinically significant illness within 4 weeks of the baseline visit; or is symptomatic for any clinically significant illness at the baseline visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214968

  Show 32 Study Locations
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

Study ID Numbers: C1538/3034/ES/MN
Study First Received: September 14, 2005
Last Updated: April 20, 2006
ClinicalTrials.gov Identifier: NCT00214968     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Physiological Effects of Drugs
Sleep Apnea, Obstructive
Nervous System Diseases
Respiration Disorders
Dyssomnias
Sleep Disorders
Central Nervous System Stimulants
Disorders of Excessive Somnolence
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Modafinil
Sleep Disorders, Intrinsic
Respiratory Tract Diseases
Narcolepsy
Mental Disorders
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010