scholarly journals Optimization of Methylphenidate Extended-Release Chewable Tablet Dose in Children with ADHD: Open-Label Dose Optimization in a Laboratory Classroom Study

2018 ◽  
Vol 28 (5) ◽  
pp. 314-321 ◽  
Author(s):  
Sharon B. Wigal ◽  
Ann Childress ◽  
Sally A. Berry ◽  
Heidi W. Belden ◽  
Phillip Chappell ◽  
...  
Keyword(s):  
Extended Release ◽  
Dose Optimization ◽  
Open Label ◽  
Chewable Tablet ◽  
Children With Adhd ◽  
Laboratory Classroom ◽  
Label Dose ◽  
Classroom Study

scholarly journals 87 Efficacy Measures in an Open-label Dose-Optimization of an Amphetamine Extended-Release Oral Suspension in Children with Attention-Deficit/Hyperactivity Disorder

CNS Spectrums ◽  
2019 ◽  
Vol 24 (1) ◽  
pp. 218-219
Author(s):  
Andrew Cutler ◽  
Antonio Pardo ◽  
Thomas R. King ◽  
Judith C. Kando ◽  
Barry K. Herman
Keyword(s):  
Primary Endpoint ◽  
Extended Release ◽  
Rating Scale ◽  
Oral Suspension ◽  
Dose Optimization ◽  
Open Label ◽  
Parent Rating ◽  
Post Dose ◽  
Duration Of Action ◽  
Label Dose

AbstractObjectivesReport the efficacy of open-label amphetamine extended-release oral suspension (AMPH EROS) for the treatment of children with ADHD.AMPH EROS has a 1-hr onset of effect and a duration of action of 13hours and was approved by FDA for treatment of ADHD in children aged 6–17 years based on a double-blind, placebo-controlled efficacy and safety study in children aged 6–12 years with ADHD. A significant treatment difference in change from pre-dose SKAMP-combined score was observed at the primary endpoint of 4hours post-dose (p<0.0001) and each post-dose time point assessed (1, 2, 4, 6, 8, 10, 12, 13hours).Data reported here are from the 5-week, open-label dose optimization period. These efficacy data support the primary endpoint result.MethodsMales and females aged 6 to 12 years with ADHD enrolled and began open-label treatment with 2.5 mg or 5mg/day of AMPH EROS titrated in 2.5–10mg/day increments until optimal dose (maximum 20mg/day). Doses could be decreased for tolerability. Subjects took morning AMPH EROS for 5weeks. Other efficacy outcomes during the open-label dose optimization phase: ADHD-RS (ADHD-Rating Scale), CGI-S (Clinical Global Impression of Severity), CGI-I (CGI-of Improvement) and CPRS (Conners’ Parent Rating Scale). All subjects were assessed for safety.ResultsFor the ITT population (n=99): treatment with AMPH EROS was associated with a mean change in ADHD-RS-IV (baseline to end of the open-label dose optimization; week 6) of 28.2 (±9.03) (Baseline score = 41.3±7.95). 90.9% of subjects had a change from baseline to open-label week 6 of ≥50% in the ADHD-RS-IV total score and were defined as responders. The CGI-S scores decreased continuously from baseline, with a high 4.8 at baseline to a low of 2.0 at open-label week 6. The percentage of subjects classified as moderately ill or greater correspondingly decreased from 97% at Baseline to 1% at open-label week 6. The decrease in the CGI-I over the study was similar to the change in CGI-S scores. CPRS for most categories decreased continuously from Baseline to open-label week 6. Mean change from baseline to open-label week 6 on the CPRS inattention T-score subscale was –25.3 (±14.38) and –24.4 (±13.87).Adverse events (>5%) reported during dose optimization were decreased appetite, insomnia, affect lability, upper abdominal pain, mood swings and headache.ConclusionAMPH EROS was effective in reducing symptoms of ADHD in this open-label dose optimization. The AE profile of AMPH EROS was consistent with those of other amphetamine products.Funding Acknowledgements: This work was funded by Tris Pharma, Inc.

scholarly journals Open-Label Dose Optimization of Methylphenidate Modified Release Long Acting (MPH-LA): A Post Hoc Analysis of Real-Life Titration from a 40-Week Randomized Trial

2014 ◽  
Vol 34 (9) ◽  
pp. 639-649 ◽  
Author(s):  
Michael Huss ◽  
Ylva Ginsberg ◽  
Torben Arngrim ◽  
Alexandra Philipsen ◽  
Katherine Carter ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Real Life ◽  
Dose Optimization ◽  
Modified Release ◽  
Open Label ◽  
Post Hoc Analysis ◽  
Label Dose ◽  
Long Acting ◽  
Post Hoc

scholarly journals Efficacy and Safety of Dasotraline in Children With ADHD: A Laboratory Classroom Study

2019 ◽  
Vol 24 (2) ◽  
pp. 192-204 ◽  
Author(s):  
Sharon B. Wigal ◽  
Seth C. Hopkins ◽  
Kenneth S. Koblan ◽  
Ann Childress ◽  
Justine M. Kent ◽  
...  
Keyword(s):  
Symptom Severity ◽  
Test Results ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Once Daily ◽  
Children With Adhd ◽  
Laboratory Classroom ◽  
Classroom Study ◽  
Math Test ◽  
Measure Of Performance

Objective: To evaluate the efficacy and safety of dasotraline for treatment of ADHD in children. Method: Children (ages 6-12 years; N = 112) with ADHD were randomized, double-blind, to 14 days of once-daily evening doses of dasotraline 4 mg or placebo. ADHD symptom severity was measured at baseline and Day 15 in seven, 30-min classroom sessions using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) and the Permanent Product Measure of Performance (PERMP) math test. Results: Significant improvement was observed for dasotraline versus placebo in the SKAMP-combined score (−3.2 vs. +2.0; p < .001; effect size = 0.85) and SKAMP and PERMP subscale scores. The three most common adverse events for dasotraline (vs. placebo) were insomnia (19.6% vs. 3.6%), headache (10.7% vs. 8.9%), and decreased appetite (10.7% vs. 3.6%). Conclusion: In this laboratory classroom study, dasotraline 4 mg was found to be an efficacious and generally well-tolerated treatment for ADHD in children aged 6 to 12 years.

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