Drug Concentration Monitoring with Tolerability and Efficacy Assessments during Open-Label, Long-Term Sertraline Treatment of Children and Adolescents

2006 ◽  
Vol 16 (1-2) ◽  
pp. 117-129 ◽  
Author(s):  
Jeffrey Alderman ◽  
Robert Wolkow ◽  
Ilan M Fogel
Keyword(s):  
Children And Adolescents ◽  
Drug Concentration ◽  
Open Label ◽  
Drug Concentration Monitoring

Time-course of treatment-emergent adverse events in a long-term safety study of lisdexamfetamine dimesylate in children and adolescents with ADHD

2016 ◽  
Vol 33 (S1) ◽  
pp. S132-S132
Author(s):  
I. Hernández Otero ◽  
T. Banaschewski ◽  
P. Nagy ◽  
C.A. Soutullo ◽  
A. Zuddas ◽  
...  
Keyword(s):  
Adverse Events ◽  
Children And Adolescents ◽  
Time Course ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Safety Population ◽  
First Onset ◽  
Stimulant Medications ◽  
Competing Interest

IntroductionThe long-term safety and efficacy of lisdexamfetamine dimesylate (LDX) in children and adolescents with attention deficit/hyperactivity disorder (ADHD) was evaluated in a European 2-year, open-label study (SPD489-404).ObjectiveTo evaluate the time-course of treatment-emergent adverse events (TEAEs) in SPD489-404.MethodsParticipants aged 6–17 years received open-label LDX (30, 50 or 70 mg/day) for 104 weeks (4 weeks dose-optimization; 100 weeks dose-maintenance).ResultsAll enrolled participants (n = 314) were included in the safety population and 191 (60.8%) completed the study. TEAEs occurred in 282 (89.8%) participants; most were mild or moderate. TEAEs considered by the investigators as related to LDX were reported by 232 (73.9%) participants with the following reported for ≥ 10% of participants: decreased appetite (49.4%), weight decreased (18.2%), insomnia (13.1%). TEAEs leading to discontinuation and serious TEAEs occurred in 39 (12.4%) and 28 (8.9%) participants, respectively. The median (range) time to first onset and duration, respectively, of TEAEs identified by the sponsor as being of special interest were: insomnia (insomnia, initial insomnia, middle insomnia, terminal insomnia), 17.0 (1–729) and 42.8 (1–739) days; weight decreased, 29.0 (1–677) and 225.0 (26–724) days; decreased appetite, 13.5 (1–653) and 169.0 (1–749) days; headache, 22.0 (1–718) and 2.0 (1–729) days. Reports of insomnia, weight decreased, decreased appetite and headache were highest in the first 4–12 weeks.ConclusionsTEAEs associated with long-term LDX treatment were characteristic of stimulant medications, with the greatest incidence observed during the first 4–12 weeks.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Long-Term Safety and Efficacy of Lisdexamfetamine Dimesylate in Children and Adolescents with ADHD: A Phase IV, 2-Year, Open-Label Study in Europe

CNS Drugs ◽  
2017 ◽  
Vol 31 (7) ◽  
pp. 625-638 ◽  
Author(s):  
David R. Coghill ◽  
Tobias Banaschewski ◽  
Peter Nagy ◽  
Isabel Hernández Otero ◽  
César Soutullo ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Open Label Study ◽  
Label Study ◽  
Safety And Efficacy ◽  
Phase Iv

scholarly journals 152 Development of Deutetrabenazine as a Potential New Non-Antipsychotic Treatment for Tourette Syndrome in Children and Adolescents

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 297-297
Author(s):  
Joseph Jankovic ◽  
Barbara Coffey ◽  
Daniel O. Claassen ◽  
David Stamler ◽  
Barry J. Gertz ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Tourette Syndrome ◽  
Neurodevelopmental Disorder ◽  
The United States ◽  
Fixed Dose ◽  
Dose Titration ◽  
Controlled Study ◽  
Antipsychotic Treatment ◽  
Open Label

Abstract:Background:Tourette syndrome (TS) is a neurodevelopmental disorder characterized by the hyperkinetic movements of motor and phonic tics manifested in young age. Currently approved treatments in the United States are antipsychotics: haloperidol, pimozide, and aripiprazole, which are associated with serious side effects, including tardive dyskinesia (TD). Deutetrabenazine, a vesicular monoamine transporter type 2 (VMAT2) inhibitor, was approved in 2017 by the US FDA for the treatment of chorea associated with Huntington’s disease and TD. Three ongoing studies (Alternatives for Reducing Tics in TS [ARTISTS]) are evaluating the efficacy, safety, and tolerability of deutetrabenazine in reducing tics in TS in children and adolescents (age 6-16 years).Methods:ARTISTS 1, a phase 2/3, response-driven, dose-titration, placebo-controlled study, randomizes patients (N=116) 1:1 to deutetrabenazine or placebo for 12 weeks. ARTISTS 2, a phase 3, fixed-dose study, randomizes patients (N=150) 1:1:1 to deutetrabenazine high or low dose, or placebo for 8 weeks. The primary efficacy outcome in these pivotal studies is change from baseline to end of treatment in the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS). Additional efficacy endpoints and safety/tolerability are also evaluated. ARTISTS is a 56-week, open-label, single-arm, long-term safety/tolerability study in patients who have successfully completed either ARTISTS 1 or ARTISTS 2.Results:Not available yet.Conclusion:TS can have potentially long-term life impact, and there remains unmet medical need for effective and well-tolerated treatments. Three ARTISTS studies will evaluate the efficacy, safety, and tolerability of deutetrabenazine in patients with tics in TS.Funding Acknowledgements:The studies are sponsored by Teva Pharmaceuticals and operationalized by Teva’s development partner, Nuvelution TS Pharma INC.

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.

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