Adaptive phase I study of OROS methylphenidate treatment of attention deficit hyperactivity disorder with epilepsy

Joseph Gonzalez-Heydrich; Jane Whitney; Deborah Waber; Peter Forbes; Olivia Hsin; Stephen V. Faraone; Alice Dodds; Sneha Rao; Christine Mrakotsky; Carlene MacMillan; David R. DeMaso; Carl de Moor; Alcy Torres; Blaise Bourgeois; Joseph Biederman

doi:10.1016/j.yebeh.2010.02.022

Adaptive phase I study of OROS methylphenidate treatment of attention deficit hyperactivity disorder with epilepsy

Joseph Gonzalez-Heydrich, Jane Whitney, Deborah Waber, Peter Forbes, Olivia Hsin, Stephen V. Faraone, Alice Dodds, Sneha Rao, Christine Mrakotsky, Carlene MacMillan, David R. DeMaso, Carl de Moor, Alcy Torres, Blaise Bourgeois, Joseph Biederman

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Abstract

Objective: The goal of this study was to pilot a randomized controlled trial of OROS methylphenidate (OROS-MPH) to treat attention deficit hyperactivity disorder (ADHD) plus epilepsy. Methods: Thirty-three patients, 6-18. years of age, taking antiepileptic drugs and with a last seizure 1-60. months prior were assigned to a maximum daily dose of 18, 36, or 54. mg of OROS-MPH in a double-blind placebo-controlled crossover trial. Results: There were no serious adverse events and no carryover effects in the crossover trial. OROS-MPH reduced ADHD symptoms more than did placebo treatment. There were too few seizures during the active (5) and placebo arms (3) to confidently assess seizure risk; however, considering exposure time, we observed an increased daily risk of seizures with increasing dose of OROS-MPH, suggesting that potential safety concerns require further study. Conclusion: A larger study to assess the effect of OROS-MPH on seizure risk is needed. A crossover design including subjects with frequent seizures could maximize power and address high patient heterogeneity and recruitment difficulties.

Original language	English
Pages (from-to)	229-237
Number of pages	9
Journal	Epilepsy and Behavior
Volume	18
Issue number	3
DOIs	https://doi.org/10.1016/j.yebeh.2010.02.022
State	Published - Jul 2010
Externally published	Yes

Keywords

Attention deficit hyperactivity disorder
Childhood seizures
Epilepsy
Methylphenidate
OROS methylphenidate
Pharmacotherapy
Seizures
Stimulant

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Gonzalez-Heydrich, J., Whitney, J., Waber, D., Forbes, P., Hsin, O., Faraone, S. V., Dodds, A., Rao, S., Mrakotsky, C., MacMillan, C., DeMaso, D. R., de Moor, C., Torres, A., Bourgeois, B., & Biederman, J. (2010). Adaptive phase I study of OROS methylphenidate treatment of attention deficit hyperactivity disorder with epilepsy. Epilepsy and Behavior, 18(3), 229-237. https://doi.org/10.1016/j.yebeh.2010.02.022

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title = "Adaptive phase I study of OROS methylphenidate treatment of attention deficit hyperactivity disorder with epilepsy",

abstract = "Objective: The goal of this study was to pilot a randomized controlled trial of OROS methylphenidate (OROS-MPH) to treat attention deficit hyperactivity disorder (ADHD) plus epilepsy. Methods: Thirty-three patients, 6-18. years of age, taking antiepileptic drugs and with a last seizure 1-60. months prior were assigned to a maximum daily dose of 18, 36, or 54. mg of OROS-MPH in a double-blind placebo-controlled crossover trial. Results: There were no serious adverse events and no carryover effects in the crossover trial. OROS-MPH reduced ADHD symptoms more than did placebo treatment. There were too few seizures during the active (5) and placebo arms (3) to confidently assess seizure risk; however, considering exposure time, we observed an increased daily risk of seizures with increasing dose of OROS-MPH, suggesting that potential safety concerns require further study. Conclusion: A larger study to assess the effect of OROS-MPH on seizure risk is needed. A crossover design including subjects with frequent seizures could maximize power and address high patient heterogeneity and recruitment difficulties.",

keywords = "Attention deficit hyperactivity disorder, Childhood seizures, Epilepsy, Methylphenidate, OROS methylphenidate, Pharmacotherapy, Seizures, Stimulant",

author = "Joseph Gonzalez-Heydrich and Jane Whitney and Deborah Waber and Peter Forbes and Olivia Hsin and Faraone, {Stephen V.} and Alice Dodds and Sneha Rao and Christine Mrakotsky and Carlene MacMillan and DeMaso, {David R.} and {de Moor}, Carl and Alcy Torres and Blaise Bourgeois and Joseph Biederman",

note = "Funding Information: This study was supported by NIMH Grant K23 MH066835. ",

year = "2010",

month = jul,

doi = "10.1016/j.yebeh.2010.02.022",

language = "English",

volume = "18",

pages = "229--237",

journal = "Epilepsy and Behavior",

issn = "1525-5050",

publisher = "Academic Press Inc.",

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Gonzalez-Heydrich, J, Whitney, J, Waber, D, Forbes, P, Hsin, O, Faraone, SV, Dodds, A, Rao, S, Mrakotsky, C, MacMillan, C, DeMaso, DR, de Moor, C, Torres, A, Bourgeois, B & Biederman, J 2010, 'Adaptive phase I study of OROS methylphenidate treatment of attention deficit hyperactivity disorder with epilepsy', Epilepsy and Behavior, vol. 18, no. 3, pp. 229-237. https://doi.org/10.1016/j.yebeh.2010.02.022

TY - JOUR

T1 - Adaptive phase I study of OROS methylphenidate treatment of attention deficit hyperactivity disorder with epilepsy

AU - Gonzalez-Heydrich, Joseph

AU - Whitney, Jane

AU - Waber, Deborah

AU - Forbes, Peter

AU - Hsin, Olivia

AU - Faraone, Stephen V.

AU - Dodds, Alice

AU - Rao, Sneha

AU - Mrakotsky, Christine

AU - MacMillan, Carlene

AU - DeMaso, David R.

AU - de Moor, Carl

AU - Torres, Alcy

AU - Bourgeois, Blaise

AU - Biederman, Joseph

N1 - Funding Information: This study was supported by NIMH Grant K23 MH066835.

PY - 2010/7

Y1 - 2010/7

N2 - Objective: The goal of this study was to pilot a randomized controlled trial of OROS methylphenidate (OROS-MPH) to treat attention deficit hyperactivity disorder (ADHD) plus epilepsy. Methods: Thirty-three patients, 6-18. years of age, taking antiepileptic drugs and with a last seizure 1-60. months prior were assigned to a maximum daily dose of 18, 36, or 54. mg of OROS-MPH in a double-blind placebo-controlled crossover trial. Results: There were no serious adverse events and no carryover effects in the crossover trial. OROS-MPH reduced ADHD symptoms more than did placebo treatment. There were too few seizures during the active (5) and placebo arms (3) to confidently assess seizure risk; however, considering exposure time, we observed an increased daily risk of seizures with increasing dose of OROS-MPH, suggesting that potential safety concerns require further study. Conclusion: A larger study to assess the effect of OROS-MPH on seizure risk is needed. A crossover design including subjects with frequent seizures could maximize power and address high patient heterogeneity and recruitment difficulties.

AB - Objective: The goal of this study was to pilot a randomized controlled trial of OROS methylphenidate (OROS-MPH) to treat attention deficit hyperactivity disorder (ADHD) plus epilepsy. Methods: Thirty-three patients, 6-18. years of age, taking antiepileptic drugs and with a last seizure 1-60. months prior were assigned to a maximum daily dose of 18, 36, or 54. mg of OROS-MPH in a double-blind placebo-controlled crossover trial. Results: There were no serious adverse events and no carryover effects in the crossover trial. OROS-MPH reduced ADHD symptoms more than did placebo treatment. There were too few seizures during the active (5) and placebo arms (3) to confidently assess seizure risk; however, considering exposure time, we observed an increased daily risk of seizures with increasing dose of OROS-MPH, suggesting that potential safety concerns require further study. Conclusion: A larger study to assess the effect of OROS-MPH on seizure risk is needed. A crossover design including subjects with frequent seizures could maximize power and address high patient heterogeneity and recruitment difficulties.

KW - Attention deficit hyperactivity disorder

KW - Childhood seizures

KW - Epilepsy

KW - Methylphenidate

KW - OROS methylphenidate

KW - Pharmacotherapy

KW - Seizures

KW - Stimulant

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U2 - 10.1016/j.yebeh.2010.02.022

DO - 10.1016/j.yebeh.2010.02.022

M3 - Article

C2 - 20493783

AN - SCOPUS:77954423766

SN - 1525-5050

VL - 18

SP - 229

EP - 237

JO - Epilepsy and Behavior

JF - Epilepsy and Behavior

IS - 3

ER -

Adaptive phase I study of OROS methylphenidate treatment of attention deficit hyperactivity disorder with epilepsy

Abstract

Keywords

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