To explore functionality and quality of life outcomes in adolescents with ADHD transitioning from IR MPH, ER MPH or ATX onto PR OROS MPH.

Pooled analyses of two similar 12 week open label, flexible dose, non-interventional trials exploring outcomes in adolescents with ADHD (ICD-10) transitioning from either IR / ER MPH, or Atomoxetine onto PR OROS MPH. Connor's parents rating scale (CPRS), children's global assessment scale (CGAS) and quality of life (ILC) were measured.

186 adolescents (84.4% boys; median age 14yrs) were analyzed. Starting dose of OROS MPH was based on clinical judgment. Median dose of PR OROS MPH at baseline and endpoint was 36mg/day. Functionality based on C-GAS as well as burden of disease scores measured in parents and adolescents improved at endpoint (p< 0.001). 80% girls and 67% of boys achieved an at least 30% reduction on CPRS. ILC-LQ0-28 in adolescents and their care givers improved (p< 0.05). 56 adolescents (30,1%) experienced at least one treatment emergent adverse event (AEs≥4% were insomnia (4,8%), headache (3,7%), muscle twitches (3,2%).

Adolescents with ADHD transitioning onto PR OROS MPH showed clinically relevant improvement in daily functioning and quality of life aspects. Burden of disease in patients and their care givers was lowered.

To explore functionality and quality of life outcomes in children and adolescents with ADHD transitioning from IR MPH, ER MPH or ATX onto OROS MPH.

Pooled analyses of two similar 12 week open label, flexibly dosed studies including children (6-18 yrs) diagnosed with ADHD (ICD-10) transitioning from shorter acting stimulants or Atomoxetine onto OROS MPH. Connor's parents rating scale, children's global assessment scale and quality of life (ILC, LQ-0-28) were applied.

822 patients (84.9% boys; median age 10 yrs) were analyzed. 81% of patients concluded the study. Starting and final dose was based on physician's judgment. Median dose at baseline and endpoint was 36mg/day. On average, C-GAS ratings improved by 12 points (p< 0.001). The percentage of children showing “variable functioning with sporadic difficulties” at baseline or worse decreased from 57,2% to 43,3% at endpoint. 61% of patients improved by at least 30% on CPRS. The percentage of children meeting educational demands at school at least “rather good” increased from 26,6% to 47,4% at endpoint. Results were similar for “social interaction with other children”, “emotional status”, “occupying with him or herself”. Burden of disease (patients or care givers) decreased (p< 0.001). Improved C-GAS and LQ 0-28 correlated with decreased CPRS. Treatment emergent AEs occurred in 35.6%. AEs ≥ 4%: insomnia (8%), muscle twitches (5%) and anorexia (4%).

Transitioning onto OROS MPH was associated with clinically relevant improvements in daily functioning, aspects of quality of life and decreased burden of disease in patients and their cares.

To explore effectiveness, quality of life outcomes, burden of disease in children and adolescents with ADHD transitioning from ER MPH or Atomoxetine onto PR OROS MPH.

Twelve week open label study including 224 patients (aged 6-18) with ADHD (ICD-10) transitioning from ER MPH (N=180), Atomoxetine (N=42) or both (N=2) onto flexibly dosed PR OROS MPH. Starting dose was based on clinical judgement. Assessments included Children's Global Assessment Scale, IOWA Conners' parent rating scale, quality of life (ILC), and open question related to late afternoon or evening activities.

224 patients (85.3% boys, median age 11 yrs) were documented. 81% completed the study. Median starting and final dose of PR OROS MPH was 36 mg/d. Mean C-GAS improved from 58 ± 15 (previous ER MPH group) and 54 ± 11 (previous ATX group) to 71±16 (12±15; p< 0,01) and 64±18 (9±16; p< 0.001), respectively.

Playing with other children, doing household chores, behavior towards visitors and doing homework were improved after switching from ATX to OROS MPH (all p < 0.05), but not for going to bed (p = 0.57). All items improved in the previous ER MPH group (p < 0.0001). Symptoms measured on IOWA Connor's rating scale as well as burden of disease (ILC) improved in children, adolescents as well as their care givers (p < 0.005).

Transition from ER MPH and ATX onto PR OROS MPH was associated with improved functionality, social interaction and decreased burden of disease in children and adolescents with ADHD.

To explore correlations of outcomes in children and adolescents with ADHD transitioning from IR MPH onto OROS MPH.

Post hoc analyses of a 12 week open label trial in patients (6-18 yrs) with a diagnosis of ADHD (ICD-10) transitioning from IR MPH onto OROS MPH. Assessments included Conners parents rating scale, children's global assessment scale and quality of life (ILC; LK0-28) of patients, including self rating and parent's rating. A regression model on difference in CPRS at endpoint from baseline as dependent variable and sex, age, baseline CPRS and diagnosis as explanatory variables was performed. Relationships between ILC, CPRS and C-GAS scores were assessed by Spearman's rank correlation coefficients.

598 patients (ITT population; 84.8% boys; median 10 yrs) received a median starting and final dose of PR OROS MPH of 36 mg/day. Scores on C-GAS, CPRS, ILC (parents and patients) improved (p< 0.001). Burden of disease in care givers and children decreased (p< 0.001). Older age, poor baseline score, diagnosis of F.90.0 (hyperkinetic disorder) were associated with greater improvements on CPRS. The difference between endpoint versus baseline scores of patient's and parent's rating of patient's ILC, C-GAS and ILC (patients'rating) correlated. ILC (parents'rating) and CPRS correlated inversely (a decrease in CAARS was associated with higher scores on ILC).

Transitioning to OROS MPH was associated with improvement in daily functioning, quality of life and decreased burden of disease. Improvement in symptoms was associated with improved quality of life aspects and better social functioning.

To explore changes in daily functioning (C-GAS) and quality of life (ILC) in children and adolescents with ADHD OROS®-MPH and their parents.

Full analysis. Open label non-interventional trial in children & adolescents with ADHD (ICD-10 criteria) treated with flexible dose OROS MPH for 3 months (42603-ATT-4001). Effectiveness parameter were C-GAS, ILC adolescents and parents and IOWA Conners' parent rating scale at baseline and endpoint.

598 patients with ADHD (ICD-10 criteria; Ø age 10.4 years ± 2.6; 84.8% male) were documented. 81.6% completed the observation. Mean OROS MPH dose at last observation was 33.5 mg/day (SD ± 13.3). Patients improved on C-GAS from 58.9±14.7 to 71.2±15.1 (p<0.001). IOWA Connors Symptoms decreased from 29.0 ± 10.5 to 18.5 ± 10.6 (p<0.0001). ILC improved from 18.8 ± 4.0 to 20.8±3.8 in children and adolescents (p<0.0001) and from 17.2±3.9 to 19.7±3.9 in parents (p<0.001). At endpoint, 76.8% of patients showed at least minimal improvement on CGI-C. Adverse events were reported in 28.8% of patients. AEs listed in ≥2% of patients were insomnia (7.7%), anorexia (3.9%), ineffectiveness (2.8%), headache (2.3%), nervousness (2.2%) and involuntary muscle contractions (2.2%). There were no significant changes in blood pressure or pulse.

Treatment with OROS®-MPH was associated with a clinically relevant improvement in daily functioning in patients with ADHD and Qol improved significantly in patients and their parents. Treatment with OROS®-MPH was well tolerated.

To investigate the effectiveness, tolerability, functionality and quality of life (QoL) under naturalistic conditions of once daily extended release methylphenidate (OROS®-MPH) in children and adolescents with attention-deficit/hyperactivity-disorder (ADHD), who had previously been treated with IR-MPH.

Interim analysis of an open-label, prospective, multicenter observational study (42603-ATT-4001) in children and adolescents aged 6-18 years with ADHD (DSM-VI). After transition patients were treated with OROS®-MPH (CONCERTA®) in flexible doses for 3 months. Primary documentation parameters were change in IOWA Conners' parent rating scale, C-GAS, and inventory for the assessment of quality of life (ILK). Statistical analyses based on ITT population (LOCF, Wilcoxon-test for dependent samples).

Data from 296 patients (mean age 10.4±2.5 years; 85% male) were documented. There was a marked reduction in symptomatology from 29±11 to 19±11 points at endpoint on the IOWA Connor's parents rating scale (p<0.0001). QoL significantly improved from 17±4 to 20±4 points on the ILK parent rating scale (p<0.0001). Functionality showed a significant improvement of 12±14 points in C-GAS (p<0.0001). 19.3% of the patients had at least one adverse event (AE). In 2 patients serious AE were documented and were rated as unrelated to OROS®-MPH. Most frequent AEs were insomnia (5.7%) and nervousness (2.7%). Tolerability after transition to OROS®-MPH was rated as "good" or "very good" by 85% of the parents.

In this naturalistic study the transition to OROS®-MPH led to a significant improvement in clinical symptomatology, functionality and quality of life in patients with ADHD. OROS®-MPH showed to be safe and well tolerated.

To explore changes in daily functioning (C-GAS) and quality of life (ILC) in adolescents (12-18 years) with ADHD treated with OROS®-MPH and their parents.

Post hoc analysis. Open label non-interventional trial in adolescents (ADHD; ICD-10 criteria) treated with flexible dose OROS-MPH for 3 months (42603-ATT-4001). Effectiveness parameter were IOWA Conners' parent rating scale, C-GAS, ILC adolescents and parents at baseline and endpoint, physician's and parents' rating of treatment.

129 out of 598 patients were adolescents (Ø age 14.2 years; 84.5% male) and 88.4% completed the study. Treatment was discontinued due to adverse events (3.9%), insufficient effectiveness (4.6%), lost to follow up (3.1%). Mean dose of OROS MPH increased from 34.6 mg/day ± 13.4 at baseline to 39.2 mg/day ± 13.4 at endpoint. C-GAS improved from 60.2 ± 14.0 to 72 ± 14.4 (p<0.001). Mean sum score on ILC-adolescents improved from 18.7 ± 3.6 to 20.6 ± 3.7 (p<0.001) and ILC-parents increased from 16.7 ± 3.9 to 19.6 ± 3.8 (p<0.001). Effectivity and tolerability was rated as at least good by >80% of physicians. 80.6% of parents were at least satisfied with therapy. 46 treatment - emergent adverse events were reported in 30 patients. AEs listed overall in ≥2% of patients were insomnia (3.9%), infection (2.3%), headache (2.3%), and nervousness (2.3%).

Transitioning onto OROS®-MPH in adolescents was associated with a clinically relevant improvement of Qol and daily functioning. Treatment with OROS MPH was well tolerated.

To explore changes in quality of life (ILC) in adolescents with attention-deficit/hyperactivity-disorder (ADHD) transitioning from Atomoxetine (ATX) or ER MPH (Medikinet retard) onto OROS MPH.

Post hoc analysis. 12 week, open label non-interventional trial in adolescents (ADHD; ICD-10 criteria) transitioning from ER MPH or Atomoxetine onto flexible dose of OROS MPHs. Effectiveness parameter were changes in IOWA Conners' parent rating scale, C-GAS, ILC adolescents and parents and questions focusing on afternoon activities.

57 adolescents were analyzed (median age 14 years, 84.2% male). Insufficient efficacy (77.2%), adverse events (3.5%) or a combination of both (19.3%) led to transition to OROS MPH. Mean dose of ER MPH prior was 34,3mg±19,3 and mean dose of atomoxetine was 53,2mg±17,9. Eight patients terminated the study prematurely. Median dose of OROS MPH at endpoint was 54mg/day. "Playing with other children", "doing household chores", "doing homework", "going to bed in the evening", and "ability to visit or receive visitors" improved (all p<0.001) as well as C-GAS (p<0.00001), Conner's parent rating scale, ILC parents and adolescent's (all p<0.001).

Adverse events (AE) with under OROS MPH treatment were reported in 45.6% of patients. AE ≥5% were involuntary muscle contractions not further specified (5.3%), insomnia (5.3%), and ineffective medication (5.3%).

Transitioning from ER MPH or ATX to OROS MPH in adolescents with ADHD was associated with an improvement in quality of life in adolescents and their parents and in daily functioning. Improved symptom control during late afternoon and early evening activities was apparent.