Source: Arthroscopy  |  Posted 5 years ago

By Paula Moyer

CHICAGO, IL -- October 12, 2006 -- An osmotic extended-release methylphenidate compound (Concerta) is effective without increasing the risk of seizure in patients with attention deficit hyperactivity disorder (ADHD) and epilepsy, according to findings presented here at the American Neurological Association (ANA) 131[^]st[] Annual Meeting.

"This formulation produced significant response rates in ADHD symptoms ? with no serious adverse events in children with epilepsy," said principal investigator Joseph M. Gonzalez-Heydrich, MD, chief, psychopharmacology program, Children's Hospital, and assistant professor of psychiatry, Harvard Medical School, Boston, Massachusetts.

In a presentation on October 9[^]th[], Dr. Gonzalez-Heydrich discussed the results of a crossover study, in which all patients took both placebo and active treatment. "There was no increase in seizures during the active treatment period compared with the placebo period," he said.

The investigators conducted the study because of the high prevalence of ADHD in children with epilepsy, ranging from 12% to 39%. However, there had been no studies of the osmotic extend-release formulation for such patients.

Therefore, the investigators randomized 27 patients with ADHD plus epilepsy, who were an average of 10.7 years old and were taking antiepileptic drugs and had been seizure-free for 1 month. The investigators randomized patients to take active treatment or placebo sequentially in a cross-over double-blind, phase 1 study. The target dose was 18 mg for 3 patients, 36 mg for 8, and 54 mg for 16 patients.

The investigators followed patients for 1 week of placebo and 1 week of active treatment. The investigators used the Clinical Global Impressions (CGI)-Improvement scores to assess response, with "much improved" or "very much improved" indicating a response. The investigators also documented all adverse events, including seizures.

The investigators documented no serious adverse events, and the weekly rate of seizures did not increase compared with baseline. Higher doses were more likely to cause a response ([]P[] < .001).

All 27 patients received 18 mg, with no discontinuations. The investigators documented 11 responses to treatment at that dose and 2 responses to placebo. The next dose, 36 mg, was used by 24 patients, with 8 discontinuations, 13 responses from the active treatment arm, and 3 responses to placebo. In the 12 patients who received the 54-mg daily dose, there were 2 discontinuations, 9 responses in the treatment arm, and 1 response in the placebo arm.

The study was supported by a grant from the National Institutes of Mental Health in Bethesda, Maryland, and by McNeil Consumer & Specialty Pharmaceuticals of Fort Washington, Pennsylvania, which manufactures Concerta.

[Presentation title: Tolerability of OROS MPH for Treatment of ADHD Plus Epilepsy. Abstract M-52]