Long-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: A multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials

2009 ◽  
Vol 31 (8) ◽  
pp. 1844-1855 ◽  
Author(s):  
Robert L. Findling ◽  
Sharon B. Wigal ◽  
Oscar G. Bukstein ◽  
Samuel W. Boellner ◽  
Howard B. Abikoff ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Clinical Trials ◽  
Attention Deficit ◽  
Phase Iii ◽  
Open Label ◽  
Hyperactivity Disorder ◽  
Term Tolerability

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.

scholarly journals Post hoc analyses of response rates to pharmacological treatments in children and adolescents with attention-deficit/hyperactivity disorder

2020 ◽  
Vol 34 (8) ◽  
pp. 874-882
Author(s):  
David R Coghill ◽  
Jeffrey H Newcorn ◽  
Jie Chen ◽  
Tamara Werner-Kiechle ◽  
Tobias Banaschewski
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Children And Adolescents ◽  
Attention Deficit ◽  
Response Rates ◽  
Open Label ◽  
Stringent Criterion ◽  
Hyperactivity Disorder ◽  
End Point ◽  
Post Hoc

Introduction and objectives: Lack of consensus regarding how best to define treatment response hinders translation from trials to the clinic. These post hoc analyses examine three commonly used response criteria in six trials of lisdexamfetamine dimesylate (LDX) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Methods: Data from four short-term randomised controlled trials (RCTs) and two long-term open-label studies were analysed. Children and adolescents with ADHD received either dose-optimised (30–70 mg/day) or fixed-dose (70 mg/day) LDX. The RCTs included osmotic-release oral system methylphenidate (OROS-MPH) or atomoxetine (ATX) as a head-to-head comparator or as a reference treatment. Three definitions of response were used in these analyses: reductions of ⩾30% or ⩾50% in ADHD Rating Scale IV (ADHD-RS-IV) total score plus a Clinical Global Impressions – Improvement (CGI-I) score of 1 or 2, or an ADHD-RS-IV total score of ⩽18. Results: At the end point, LDX response rates for the least stringent criterion of ⩾30% reduction in ADHD-RS-IV total score plus a CGI-I score of 1 or 2 ranged from 69.6% to 82.6%. The proportion achieving the more stringent criterion of a reduction in ADHD-RS-IV total score of ⩾50% plus a CGI-I score of 1 or 2 at the end point ranged from 59.8% to 74.8%. An ADHD-RS-IV total score of ⩽18 at the end point was achieved by 56.7–79.9% of participants. Response rates remained stable throughout the long-term open-label studies. Conclusions: Response rates were similar for the two more stringent response criteria. The less stringent criterion resulted in higher response rates and may include partial responders.

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 Long-Term Safety and Effectiveness of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder

CNS Spectrums ◽  
2009 ◽  
Vol 14 (10) ◽  
pp. 573-586 ◽  
Author(s):  
Richard Weisler ◽  
Joel Young ◽  
Greg Mattingly ◽  
Joseph Gao ◽  
Liza Squires ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Adverse Events ◽  
Attention Deficit ◽  
Rating Scale ◽  
Upper Respiratory Tract ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Double Blind ◽  
Hyperactivity Disorder

ABSTRACTObjective: To evaluate the long-term safety and effectiveness of lisdexamfetamine dimesylate (LDX) in the treatment of adults with attention-deficit/hyperactivity disorder (ADHD).Methods: Following a 4-week, placebo-controlled, double-blind trial, 349 adults with ADHD were enrolled into an open-label, single-arm study for up to 12 months. Treatment was initiated at 30 mg/day and titrated up to 70 mg/day at subsequent visits to achieve optimal effectiveness and tolerability. Safety assessments included adverse events inquiries, vital signs, and electrocardiograms while the primary effectiveness assessment was the ADHD Rating Scale (ADHD-RS) total score.Results: A total of 191 (54.7%) subjects completed the study. The most common treatment-emergent adverse events (TEAEs) were upper respiratory tract infection (21.8%), insomnia (19.5%), headache (17.2%), dry mouth (16.6%), decreased appetite (14.3%), and irritability (11.2%). Most TEAEs were mild to moderate in severity. At endpoint, small but statistically significant increases in pulse and blood pressure were noted. Significant improvements in mean ADHD-RS total scores were observed at week 1 and sustained throughout the study (P<.0001 at all postbaseline visits). At endpoint, the mean improvement from baseline ADHD-RS total score was 24.8 (P<.0001).Conclusions: LDX demonstrated a safety profile consistent with long-acting stimulant use and provided continued effectiveness in adults with ADHD for up to 12 months.

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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