Scroll Up
Scroll Down
Play Play Play Play
Unregistered User
Click here if this is not your Personal Edition
 
Contact Us | Free E-Mail Updates | Journals | Register a colleague
 
 
Paediatrics
 
   
 
SEARCH   
Doctor's Guide Free CME
Medline
Congress Resource Centre
 

 EXPLORE :
   Most Read News
 All News  All News
 All Webcasts / CME  All Webcasts / CME
 All Cases  All Cases
 Congress Resource Centre  Congress Resource Centre
 All Medical Resources  All Medical Resources
 Medical  My Personal Edition



Warning | Privacy

 

 
 Recent news - Paediatrics
    Bipolar Disorder in Children Appears Likely to Continue Into Young Adulthood - (DGNews)
    Flu Vaccine Not Associated With Reduced Hospitalisations or Outpatient Visits Among Young Children - (DGNews)
    Alternatives for Radiation of Low-Grade Glioma Prove Effective in Paediatric Patients - (DGNews)
    Major Study of Opiate Use in Children's Hospitals Provides Simple Steps to Alleviate Harm - (DGNews)
    Procalcitonin Can Help Identify Infants at High Risk for Serious Bacterial Infections - (DGNews)

    News archive

     Recent webcasts/CME - Paediatrics
      Fetal Alcohol Spectrum Disorders (FASD): What it as and How it Affects the Child, the Family and Society: FASD and its Effects II
      Fetal Alcohol Spectrum Disorders (FASD): What it is and How it Affects the Child, the Family and Society: FASD and its Effects I
      Assessment, Prevention and Treatment of Childhood Obesity
      Roadmaps for Clinical Practice series: Improving Adolescent Immunizations: A Primer for Physicians
      The Current and Future State of Asthma Treatment

      Webcasts/CME archive

       Recent cases - Paediatrics
        Menkes Kinky Hair Disease: A Case Report
        Mosaic 22q11.2 Microdeletion Syndrome: Diagnosis and Clinical Manifestations of Two Cases
        Analphoid Supernumerary Marker Chromosome Characterized By aCGH and FISH as inv dup(3)(q25.33qter) De Novo in a Child with Dysmorphic Features and Streaky Pigmentation: Case Report
        Congenital Contractures and Distinctive Phenotypic Features Consistent with Stuve-Wiedmann Syndrome in a Male Infant
        Extrinsic Post Burn Peri-Anal Contracture Leading to Sub Acute Intestinal Obstruction: A Case Report

        Cases archive
          




        my personal edition > paediatrics > news
        divider

          E-Mail this DGNews to a colleague

        DGNews


        Pediatrics Publishes Pivotal Study Showing Sparlon Significantly Improves ADHD Symptoms in Children and Adolescents

        FRAZER, PA -- December 5, 2005 -- Cephalon, Inc. today announced that results of a clinical study evaluating Sparlon(TM) (modafinil) Tablets [C-IV] for the treatment of attention- deficit/hyperactivity disorder (ADHD) in children and adolescents have been published in this month's issue of Pediatrics, the peer-reviewed journal of the American Academy of Pediatrics.

        In the study, Sparlon significantly improved the symptoms associated with ADHD as reported by physicians, parents and teachers, and was generally well tolerated.

        "In this study, children and adolescents treated with once-daily Sparlon showed improvement in ADHD symptoms, including inattention, impulsivity, and hyperactivity, both at school and at home," said Joseph Biederman, MD, chief, Department of Pediatric Psychopharmacology, Massachusetts General Hospital, professor of Psychiatry at Harvard Medical School, and a lead investigator in the trial. "Sparlon also was associated with a favorable side effect profile."

        About the Study
        The published study is one of three pivotal studies of Sparlon for the treatment of ADHD in children and adolescents. The 9-week, double-blind, flexible-dose study included 248 children and adolescents with ADHD (ages 6 to 17 years) who were randomized to either once-daily Sparlon or placebo.

        The primary endpoint was the teacher/physician-completed ADHD Rating Scale-IV (ADHD-RS-IV) School Version total score. Symptom improvement also was rated using a variety of other scales, including evaluations by parents.

        In the study, patients treated with Sparlon showed significantly greater improvement than with placebo in the core symptoms of ADHD at school and home (both P <.0001). By the end of the study, 48 percent of patients treated with Sparlon were rated by physicians as "much" or "very much" improved compared with 17 percent of patients who received placebo (P <.0001).

        In the study, Sparlon was generally well tolerated and discontinuation rates due to adverse events were not significantly different from placebo. The most common adverse events associated with Sparlon were generally mild to moderate in nature and included insomnia, headache and decreased appetite.

        Sparlon
        Sparlon is a new dosage form of modafinil, the active ingredient in Provigil(R) (modafinil) Tablets [C-IV], which is approved for the treatment of adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. Provigil is not approved to treat ADHD. Cephalon has submitted data to the FDA requesting approval to market Sparlon for the treatment of ADHD in children and adolescents. The FDA has not yet determined that Sparlon is safe and effective. If approved, Sparlon is expected to be available in early 2006.


        SOURCE: Cephalon, Inc.



        E-Mail this DGNews to a colleague   To print, use this version






        All contents Copyright (c) 1995-2008 Doctor's Guide Publishing Limited. All rights reserved.



        The NTK initiative. Physicians helping physicians identify Need-To-Know science
           Feedback
        Please rate this article: Strongly DISAGREE...Strongly AGREE NTK logo
        Question 1 - Physicians need to become aware of this information as soon as possible. Question 2 - This information is likely to have an impact on the way physicians practice medicine.
        1
        2
        3
        4
        5
        6
        7
        Send