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
  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
Narcolepsy
Drug: Modafinil
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 92
Study Start Date: January 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Modafinil
maximum dosage 400 mg/day (4 tablets)
Other Name: Provigil

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00214968     History of Changes
Other Study ID Numbers: C1538/3034/ES/MN
Study First Received: September 14, 2005
Last Updated: May 23, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014