4.7 EFFICACY OF METHYLPHENIDATE EXTENDED-RELEASE CHEWABLE TABLETS IN CHILDREN WITH ATTENTION-DEFICIT/HYPERACTIVITY DISORDER: OPEN-LABEL, DOSE-OPTIMIZATION PERIOD OUTCOMES

2016 ◽  
Vol 55 (10) ◽  
pp. S164-S165
Author(s):  
Sharon B. Wigal ◽  
Ann Catherine Childress ◽  
Sally Berry ◽  
Heidi Belden ◽  
Phillip B. Chappell ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Extended Release ◽  
Dose Optimization ◽  
Open Label ◽  
Hyperactivity Disorder ◽  
Label Dose ◽  
Chewable Tablets

scholarly journals Correction to: Safety and efficacy of guanfacine extended-release in adults with attention-deficit/hyperactivity disorder: an open-label, long-term, phase 3 extension study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Akira Iwanami ◽  
Kazuhiko Saito ◽  
Masakazu Fujiwara ◽  
Daiki Okutsu ◽  
Hironobu Ichikawa
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Extended Release ◽  
Extension Study ◽  
Open Label ◽  
Phase 3 ◽  
Safety And Efficacy ◽  
Hyperactivity Disorder

An amendment to this paper has been published and can be accessed via the original article.

An Open-Label, Dose-Ranging Study of Atomoxetine in Children with Attention Deficit Hyperactivity Disorder

2001 ◽  
Vol 11 (3) ◽  
pp. 251-265 ◽  
Author(s):  
Thomas Spencer ◽  
Joseph Biederman ◽  
John Heiligenstein ◽  
Timothy Wilens ◽  
Douglas Faries ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Open Label ◽  
Hyperactivity Disorder ◽  
Label Dose ◽  
Dose Ranging

scholarly journals Characteristics of ADHD Symptom Response/Remission in a Clinical Trial of Methylphenidate Extended Release

2019 ◽  
Vol 8 (4) ◽  
pp. 461 ◽  
Author(s):  
Margaret Weiss ◽  
Ann Childress ◽  
Earl Nordbrock ◽  
Akwete Adjei ◽  
Robert Kupper ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Extended Release ◽  
Rating Scale ◽  
Phase Iii ◽  
Open Label ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
Percent Change

Clinical trials in attention-deficit/hyperactivity disorder (ADHD) have typically measured outcome using clinician ratings on the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) and the Clinical Global Impression-Improvement (CGI-I) scale. Remission has been defined as an endpoint score of less than or equal to 18 on the ADHD-RS-IV (or a mean score of 1). Responders have been defined as patients who achieve a CGI-I score of much or very much improved (1 or 2). There is a lack of agreement in the literature on what percent change in symptoms on the ADHD-RS-IV should be used to define improvement or remission. This study uses data from a clinical trial of a methylphenidate extended release (MPH-MLR; Aptensio XR®) phase III clinical trial to attempt to determine the percent change of symptoms that best corresponds with improvement and remission. Symptom remission at endpoint (ADHD-RS-IV total score ≤18) was most closely aligned with a ≥46% reduction in ADHD-RS-IV total score. Clinical improvement was most closely aligned with a ≥40% reduction in ADHD-RS-IV total score. The three different measures of outcome were strongly aligned during double blind and open label treatment, and were independent of subtype status. Our data suggest that at least 40% improvement in symptoms is needed to achieve a robust response at endpoint.

scholarly journals Safety and efficacy of guanfacine extended-release in adults with attention-deficit/hyperactivity disorder: an open-label, long-term, phase 3 extension study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Akira Iwanami ◽  
Kazuhiko Saito ◽  
Masakazu Fujiwara ◽  
Daiki Okutsu ◽  
Hironobu Ichikawa
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Executive Functioning ◽  
Outcome Measures ◽  
Attention Deficit ◽  
Extended Release ◽  
Open Label ◽  
Phase 3 ◽  
Safety And Efficacy ◽  
Hyperactivity Disorder

Abstract Background To assess the safety and efficacy of long-term administration of guanfacine extended-release (GXR) in adults with attention-deficit/hyperactivity disorder (ADHD). Methods In this open-label, long-term, phase 3 extension study in Japan, 150 patients transitioned from a double-blind trial, and 41 newly enrolled patients received once daily GXR (starting dose 2 mg/day, maintenance dose 4–6 mg/day) for 50 weeks. Primary outcome measures were the frequency and nature of treatment-emergent adverse events (TEAEs); secondary outcome measures included the change from week 0 in ADHD Rating Scale IV with Adult Prompts (ADHD-RS-IV; Japanese version) total and subscale scores, Conners’ Adult ADHD Rating Scales (CAARS), Clinical Global Impression-Improvement (CGI-I) and Patient Global Impression-Improvement (PGI-I) scales, and quality of life (QoL) and executive functioning measures. Results Of all patients, 94.2% (180/191) reported ≥1 TEAE and 19.9% (38/191) discontinued because of a TEAE. Most TEAEs were mild to moderate in severity; there were two serious TEAEs and no deaths. Commonly reported TEAEs (≥10% of patients) were somnolence, thirst, nasopharyngitis, decreased blood pressure, postural dizziness, bradycardia, malaise, constipation, and dizziness. Mean changes from week 0 in ADHD-RS-IV total and subscale scores and CAARS subscale scores were significantly improved in former placebo or GXR patients and new patients at last observation (p < .0001), and the percentage of patients with very much or much improved CGI-I and PGI-I scores increased. Conclusions There were no major safety concerns during long-term GXR administration in adults with ADHD. After long-term treatment, patients had significant improvements from baseline in ADHD symptoms, QoL, and executive functioning. Trial registration Japan Primary Registries Network (https://rctportal.niph.go.jp/en/): JapicCTI-163232, registered 04/21/2016.

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