Open-label (OL) extension trial of the safety and tolerability of OROS® methylphenidate in adults with ADHD – the long-acting methylphenidate in adult ADHD (LAMDA) trial

Objective: To evaluate safety and tolerability of OROS MPH in a flexible dose, open-label study in adults with ADHD. Methods: Adults aged 18–65 y with a diagnosis of ADHD who participated in the placebo-controlled LAMDA trial, and met inclusion criteria for the 7-week OL extension phase were enrolled. Per-protocol, the starting dose of OROS MPH was 36mg/d; however, approximately one-quarter of subjects started on 18mg/d. To optimize efficacy and tolerability for each patient, dose was adjusted in increments of 18mg based on investigators' judgement of clinical response. CAARS and other variables were assessed throughout. Median final dose was 54mg/day. Safety assessments included AE, vital signs, and laboratory parameters. Results: 371 subjects entered the OL phase. After 1 week of treatment with OROS MPH, total CAARS score improved in patients previously receiving plac (n=92; P<0.001). All subsequent assessments showed improvements in CAARS score compared with OL baseline (n=363; P<0.001), regardless of preceding treatment type (active or plac) during DB phase. Most frequently reported AE were headache (17%), decreased appetite (13%), insomnia (11%). 17 subjects discontinued treatment due to AE. BMI was reduced relative to baseline (P<0.05). 1 week after the last dose of study medication, CAARS score had deteriorated significantly (P<0.001). Conclusion: In this open-label study OROS MPH was generally safe and well-tolerated and efficacy was maintained in adults with ADHD.

This study was supported by Janssen-Cilag GmbH