Efficacy and Safety of Ritalin® LA™, a New, Once Daily, Extended-Release Dosage Form of Methylphenidate, in Children with Attention Deficit Hyperactivity Disorder (original) (raw)

Abstract

Objective: To evaluate the safety and efficacy of extended-release methylphenidate with a bimodal profile using SODAS™ technology (Ritalin® LA™) compared with placebo in children aged 6–14 years with attention deficit hyperactivity disorder (ADHD).

Method: This was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study in children meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for ADHD. Following titration and a 1-week placebo washout period, patients were randomized to 2 weeks of double-blind treatment with either Ritalin® LA™ (10–40) mg/day) or placebo. The efficacy assessments used were the Conners’ ADHD/DSM-IV Scales for teachers (CADS-T) and for parents (CADS-P), and the Clinical Global Impression-Improvement Scale (CGI-I) completed by the investigator. The primary efficacy variable was the change from baseline (end of placebo washout) to the final rating (end of 2-week double-blind treatment) in the CADS-T Total subscale score.

Results: One-hundred-and-sixty-one children were treated and 134 responders were included in the intent-to-treat analysis. Ritalin® LA™ achieved a mean change from baseline (± SD) on the CADS-T Total subscale of –10.7 (±15.68) compared with 2.8 (±10.59) for placebo (p < 0.0001); the effect size on the CADS-T Total score with Ritalin® LA™ was 0.90. Additionally, 69.8% of patients in the Ritalin® LA™ group were rated as much or very much improved on the CGI-I at final assessment compared with 40% of patients in the placebo group (p = 0.0009). The adverse events reported were generally mild or moderate, and were similar in both groups.

Conclusion: The results demonstrate that Ritalin® LA™ administered once daily for up to 2 weeks achieved outcomes statistically superior to placebo in children with ADHD.

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Acknowledgements

We would like to thank James Swanson, PhD, University of California, and Child Development Center, Irvine, CA, USA; Thomas Spencer, MD, Pediatric Psychopharmacology Clinic of the Massachusetts General Hospital, Boston, MA, USA; C. Keith Conners, PhD, Duke University, Durham, NC, USA; and Herbert Faleck, OD, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, for their contributions to the discussion of the study design. In addition, we thank C. Keith Conners, PhD, for providing the CADS efficacy scales. This study was supported by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.

Dr Weiss has been a clinical investigator, a speaker, and an advisory board member for Novartis Pharmaceuticals Corporation. Dr Quinn has no current affiliation with Novartis Pharmaceuticals Corporation, but did receive a grant from Novartis 2 years ago. Dr Wigal is a member of the Novartis Pharmaceuticals Corporation advisory board and speaker’s bureau, and has also received research support from Novartis Pharmaceuticals Corporation.

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Authors and Affiliations

  1. Massachusetts General Hospital, 55 Fruit St, Warren Building 705, Boston, Massachusetts, 02114, USA
    Joseph Biederman
  2. Royal University Hospital, Saskatoon, Saskatchewan, Canada
    Declan Quinn
  3. Children and Women’s Health Centre of British Columbia, Vancouver, British Columbia, Canada
    Margaret Weiss
  4. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA
    Sabri Markabi & Meredith Weidenman
  5. Novartis Pharma AG, Basel, Switzerland
    Kathryn Edson, Goeril Karlsson & Harald Pohlmann
  6. University of California, Irvine, California, USA
    Sharon Wigal

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  1. Joseph Biederman
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  2. Declan Quinn
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  3. Margaret Weiss
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  4. Sabri Markabi
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  5. Meredith Weidenman
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  6. Kathryn Edson
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  7. Goeril Karlsson
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Biederman, J., Quinn, D., Weiss, M. et al. Efficacy and Safety of Ritalin® LA™, a New, Once Daily, Extended-Release Dosage Form of Methylphenidate, in Children with Attention Deficit Hyperactivity Disorder.Pediatr-Drugs 5, 833–841 (2003). https://doi.org/10.2165/00148581-200305120-00006

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