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P.7.c.002 Quality of life and parent satisfaction with the methylphenidate transdermal system
S562
P.7.c Child and adolescent disorders and treatment – Treatment (clinical)
and correct) at all measured time points beginning at 2 hours and throughout the last classroom assessment at 10 hours after patch application. Within two hours of patch removal, mean SKAMP and PERMP scores progressively approached pre-patch application level (Baseline) for both the 4- and 6-hour MTS wear times. These results indicate that the duration of effect of MTS is proportional to the length of time the patch is worn.
P.7.c.002 Quality of life and parent satisfaction with the methylphenidate transdermal system 1 Children’s F.A. L´opez1 ° , J.M. Landgraf2 , T.E. Wilens3 . Developmental Center, Winter Park, USA; 2 HealthActCHQ Inc, Boston, USA; 3 Harvard Medical School – Massachusetts General Hospital, Pediatric Psychopharmacology Unit, Boston, USA
Objective: The objective of this report is to evaluate child and parent satisfaction with the efficacy and tolerability of methylphenidate transdermal system (MTS) using the ADHD Impact Module-Children (AIM-C) and a Parent Medication Satisfaction Survey (MSS). These evaluations were conducted as part of a controlled efficacy study. Methods: This was a randomized, double-blind, placebocontrolled, 3-way crossover, laboratory classroom study of MTS. Children aged 6−12 years diagnosed with attentiondeficit/hyperactivity disorder (ADHD) by DSM-IV-TR criteria were enrolled. Subjects were initiated on 10-mg MTS and titrated to optimal dose (up to 30 mg) over 5 weeks using a 9-hour wear time. Following dose optimization, subjects were randomized to treatment sequences of MTS worn 4 hours, MTS worn 6 hours, and placebo for the laboratory classroom days (one day per week for 3 weeks). Overall treatment duration was 8 weeks. Subjects were assessed using standardized measures of behavior and classroom performance. The AIM-C and MSS were used as secondary endpoints to evaluate child and parent satisfaction with MTS. The AIM-C quality of life survey measures the impact of ADHD on children and their families. It is comprised of Likerttype scales and questions about fluctuations in children’s daily behavior off medication, difficulty handling these changes, and the number of missed work and school days. The AIM-C was completed at baseline and Weeks 5 (final dose optimization visit) and 8 (final laboratory classroom visit). The MSS survey assesses parent and child satisfaction with study medication. The MSS was administered at Week 5 to assess satisfaction with the optimized MTS dose and again at Week 8. Table 1. Mean AIM-C Child and Family Impact Scores at baseline and study endpoint AIM-C Baseline Scale
Study endpoint score*, mean (SD)
score, mean All Doses (SD)
10 mg
15 mg
20 mg
30 mg
Child 35.3 (16.1) 73.6 (17.8) 69.0 (18.0) 80.7 (14.0) 74.3 (18.8) 69.4 (19.3) Impact Family 43.6 (24.8) 79.4 (22.2) 80.5 (24.2) 81.0 (20.9) 83.0 (20.8) 74.2 (24.1) Impact *Higher score indicates improvement.
Results: 128 subjects were enrolled. Mean AIM-C scores increased (improved) from baseline to study endpoint across all four MTS doses (Table 1). Parents generally felt that changes in their child’s behavior were less difficult to handle at Endpoint. More parents reported ‘no missed work days’ during the past 2 months due to problems with their child’s ADHD at Endpoint compared
with Baseline (97% and 91%, respectively). More parents reported ‘no missed school days’ at Endpoint compared with Baseline (94% and 84%, respectively). 94% of parents agreed with the MSS statement that overall, they were satisfied with MTS as a treatment for their child’s ADHD. Most adverse events with MTS treatment were mild to moderate in intensity. Conclusions: At study endpoint, most parents reported improvements in quality of life measures, and the majority of parents were satisfied with the effectiveness and ease of use of MTS as an ADHD treatment for their child. MTS treatment appeared to positively impact the quality of life for children with ADHD and their families.
P.7.c.003 12-month safety and efficacy of methylphenidate transdermal system in attention-deficit/hyperactivity disorder J.M. Turnbow1 ° , R.L. Findling2 , F.A. L´opez3 , J.C. Burnside4 , 1 Westex Clinical Investigations, Lubbock, O.G. Bukstein5 . USA; 2 Case Western University – University Hospitals Case Medical Center, Child & Adolescent Psychiatry, Cleveland, USA; 3 Children’s Developmental Center, Winter Park, USA; 4 The ADHD Clinic of San Antonio, San Antonio, USA; 5 University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, USA Objective: Several clinical trials document the efficacy and safety of short-term treatment with the methylphenidate transdermal system (MTS) in children with attention-deficit/hyperactivity disorder (ADHD); however, effects of long-term use have not been systematically evaluated. The aim of this study was to report on the long-term (up to 12 months) safety and efficacy of MTS in the symptomatic treatment of pediatric subjects with ADHD. Method: This was a 12-month, multicenter, open-label, flexible dose extension of 4 trials in subjects previously exposed to MTS (range of 3 days up to 42 weeks), osmotic-release oral system methylphenidate (OROS MPH), or placebo. Children, aged 6−12 years, diagnosed with ADHD by DSM-IV-TR criteria either continued their current optimized MTS dose for 12 months or entered a 4-week stepwise dose titration phase to an optimal MTS dose, followed by an 11-month dose maintenance phase. Adverse events were recorded throughout the study. Evaluation of dermal response to MTS was rated on a scale ranging from 0 to 7 where scores were defined as: 0, no evidence of irritation; 1, minimal erythema; 2, definite erythema; 3, erythema and papules; 4, definite edema; 5, erythema, edema, and papules; 6, vesicular eruption; 7, strong reaction beyond patch site. The main efficacy measure was the ADHD Rating Scale-IV (ADHD-RS-IV). Others included the Clinical Global Impressions-Improvement scale (CGI-I) and the Parent Global Assessment scale (PGA). The CGI-I and PGA ratings were dichotomized into 2 categories: IMPROVED (included responses of ’much improved’ and ’very much improved’) and NOT IMPROVED (all other response levels). All efficacy measures were assessed weekly for the first 4 weeks, monthly for months 2−6, and every 2 months thereafter. Results: A total of 327 subjects enrolled; 326 received treatment and 157 completed all 12 months of the study. The mean (SD) age of all enrolled subjects was 9.2 (1.9) years of age. The median exposure time to MTS (including exposure in the previous studies) was 335 days (range, 7 to 392 days). The most common adverse events (10%) included decreased appetite, headache, upper respiratory tract infection, cough, pyrexia, and decreased
P.7.c Child and adolescent disorders and treatment – Treatment (clinical)
and correct) at all measured time points beginning at 2 hours and throughout the last classroom assessment at 10 hours after patch application. Within two hours of patch removal, mean SKAMP and PERMP scores progressively approached pre-patch application level (Baseline) for both the 4- and 6-hour MTS wear times. These results indicate that the duration of effect of MTS is proportional to the length of time the patch is worn.
P.7.c.002 Quality of life and parent satisfaction with the methylphenidate transdermal system 1 Children’s F.A. L´opez1 ° , J.M. Landgraf2 , T.E. Wilens3 . Developmental Center, Winter Park, USA; 2 HealthActCHQ Inc, Boston, USA; 3 Harvard Medical School – Massachusetts General Hospital, Pediatric Psychopharmacology Unit, Boston, USA
Objective: The objective of this report is to evaluate child and parent satisfaction with the efficacy and tolerability of methylphenidate transdermal system (MTS) using the ADHD Impact Module-Children (AIM-C) and a Parent Medication Satisfaction Survey (MSS). These evaluations were conducted as part of a controlled efficacy study. Methods: This was a randomized, double-blind, placebocontrolled, 3-way crossover, laboratory classroom study of MTS. Children aged 6−12 years diagnosed with attentiondeficit/hyperactivity disorder (ADHD) by DSM-IV-TR criteria were enrolled. Subjects were initiated on 10-mg MTS and titrated to optimal dose (up to 30 mg) over 5 weeks using a 9-hour wear time. Following dose optimization, subjects were randomized to treatment sequences of MTS worn 4 hours, MTS worn 6 hours, and placebo for the laboratory classroom days (one day per week for 3 weeks). Overall treatment duration was 8 weeks. Subjects were assessed using standardized measures of behavior and classroom performance. The AIM-C and MSS were used as secondary endpoints to evaluate child and parent satisfaction with MTS. The AIM-C quality of life survey measures the impact of ADHD on children and their families. It is comprised of Likerttype scales and questions about fluctuations in children’s daily behavior off medication, difficulty handling these changes, and the number of missed work and school days. The AIM-C was completed at baseline and Weeks 5 (final dose optimization visit) and 8 (final laboratory classroom visit). The MSS survey assesses parent and child satisfaction with study medication. The MSS was administered at Week 5 to assess satisfaction with the optimized MTS dose and again at Week 8. Table 1. Mean AIM-C Child and Family Impact Scores at baseline and study endpoint AIM-C Baseline Scale
Study endpoint score*, mean (SD)
score, mean All Doses (SD)
10 mg
15 mg
20 mg
30 mg
Child 35.3 (16.1) 73.6 (17.8) 69.0 (18.0) 80.7 (14.0) 74.3 (18.8) 69.4 (19.3) Impact Family 43.6 (24.8) 79.4 (22.2) 80.5 (24.2) 81.0 (20.9) 83.0 (20.8) 74.2 (24.1) Impact *Higher score indicates improvement.
Results: 128 subjects were enrolled. Mean AIM-C scores increased (improved) from baseline to study endpoint across all four MTS doses (Table 1). Parents generally felt that changes in their child’s behavior were less difficult to handle at Endpoint. More parents reported ‘no missed work days’ during the past 2 months due to problems with their child’s ADHD at Endpoint compared
with Baseline (97% and 91%, respectively). More parents reported ‘no missed school days’ at Endpoint compared with Baseline (94% and 84%, respectively). 94% of parents agreed with the MSS statement that overall, they were satisfied with MTS as a treatment for their child’s ADHD. Most adverse events with MTS treatment were mild to moderate in intensity. Conclusions: At study endpoint, most parents reported improvements in quality of life measures, and the majority of parents were satisfied with the effectiveness and ease of use of MTS as an ADHD treatment for their child. MTS treatment appeared to positively impact the quality of life for children with ADHD and their families.
P.7.c.003 12-month safety and efficacy of methylphenidate transdermal system in attention-deficit/hyperactivity disorder J.M. Turnbow1 ° , R.L. Findling2 , F.A. L´opez3 , J.C. Burnside4 , 1 Westex Clinical Investigations, Lubbock, O.G. Bukstein5 . USA; 2 Case Western University – University Hospitals Case Medical Center, Child & Adolescent Psychiatry, Cleveland, USA; 3 Children’s Developmental Center, Winter Park, USA; 4 The ADHD Clinic of San Antonio, San Antonio, USA; 5 University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, USA Objective: Several clinical trials document the efficacy and safety of short-term treatment with the methylphenidate transdermal system (MTS) in children with attention-deficit/hyperactivity disorder (ADHD); however, effects of long-term use have not been systematically evaluated. The aim of this study was to report on the long-term (up to 12 months) safety and efficacy of MTS in the symptomatic treatment of pediatric subjects with ADHD. Method: This was a 12-month, multicenter, open-label, flexible dose extension of 4 trials in subjects previously exposed to MTS (range of 3 days up to 42 weeks), osmotic-release oral system methylphenidate (OROS MPH), or placebo. Children, aged 6−12 years, diagnosed with ADHD by DSM-IV-TR criteria either continued their current optimized MTS dose for 12 months or entered a 4-week stepwise dose titration phase to an optimal MTS dose, followed by an 11-month dose maintenance phase. Adverse events were recorded throughout the study. Evaluation of dermal response to MTS was rated on a scale ranging from 0 to 7 where scores were defined as: 0, no evidence of irritation; 1, minimal erythema; 2, definite erythema; 3, erythema and papules; 4, definite edema; 5, erythema, edema, and papules; 6, vesicular eruption; 7, strong reaction beyond patch site. The main efficacy measure was the ADHD Rating Scale-IV (ADHD-RS-IV). Others included the Clinical Global Impressions-Improvement scale (CGI-I) and the Parent Global Assessment scale (PGA). The CGI-I and PGA ratings were dichotomized into 2 categories: IMPROVED (included responses of ’much improved’ and ’very much improved’) and NOT IMPROVED (all other response levels). All efficacy measures were assessed weekly for the first 4 weeks, monthly for months 2−6, and every 2 months thereafter. Results: A total of 327 subjects enrolled; 326 received treatment and 157 completed all 12 months of the study. The mean (SD) age of all enrolled subjects was 9.2 (1.9) years of age. The median exposure time to MTS (including exposure in the previous studies) was 335 days (range, 7 to 392 days). The most common adverse events (10%) included decreased appetite, headache, upper respiratory tract infection, cough, pyrexia, and decreased