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(12) United States Patent (10) Patent No.: US 8,957,099 B2 Bird (45) Date of Patent: Feb

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(12) United States Patent (10) Patent No.: US 8,957,099 B2 Bird (45) Date of Patent: Feb US008957099B2 (12) United States Patent (10) Patent No.: US 8,957,099 B2 Bird (45) Date of Patent: Feb. 17, 2015 (54) TREATMENT OF ADHD (56) References Cited (75) Inventor: Philip Bird, Maroochydore (AU) U.S. PATENT DOCUMENTS 2002fOO5865.6 A1 5, 2002 Ockert (73) Assignee: Gosforth Centre (Holdings) Pty Ltd., 2003/0060423 A1 3/2003 Plata-Salaman Maroochydore, Queensland (AU) 2004/O258758 A1 12/2004 Gustow et al. 2006/0052428 A1* 3/2006 Chez ............................. 514,396 (*) Notice: Subject to any disclaimer, the term of this 2011/0065628 A1 3/2011 Johnson et al. patent is extended or adjusted under 35 2011/02O7718 A1 8, 2011 Bird U.S.C. 154(b) by 895 days. FOREIGN PATENT DOCUMENTS (21) Appl. No.: 12/526,191 EP 1600 167 A2 11/2005 WO WO93,21910 A1 11, 1993 (22) PCT Filed: Feb. 7, 2008 WO WOO1/39779 A1 6, 2001 WO WO 03/O13514 A1 2, 2003 (86). PCT No.: PCT/AU2O08/OOO154 WO WOO3,O3O899 A2 4/2003 WO 2004.002462 1, 2004 S371 (c)(1), WO WO 2006/120501 A1 11, 2006 WO WO 2008/095221 A1 8, 2008 (2), (4) Date: Oct. 20, 2009 WO WO 2009/O14762 A1 1, 2009 WO WO 2009/139901 A2 11/2009 (87) PCT Pub. No.: WO2008/095253 WO WO 2010/O15O29 A1 2, 2010 WO WO 2011/10O373 A1 8, 2011 PCT Pub. Date: Aug. 14, 2008 WO WO 2011, 143721 A1 11, 2011 (65) Prior Publication Data OTHER PUBLICATIONS US 201O/OO87422 A1 Apr. 8, 2010 Schaller et al., “Carbamazepine and methylphenidate in ADHD.” Journal of the American Academy of Child and Adolescent Psychia try, 38:2, Feb. 1999, pp. 112-113. Related U.S. Application Data EPO, Supplementary European Search Report for European applica tion No. EP08700447, Munich, Germany, Mar. 11, 2010. (63) Continuation-in-part of application No. Frank, “Visual Event Related Potentials. After Methylphenidate and PCT/AU2007/000421, filed on Mar. 30, 2007. Sodium Valproate in Children with Attention Deficit Hyperactivity Disorder.” Clinical Electroencephalography, 1993, pp. 19-24, vol. (60) Provisional application No. 60/900,043, filed on Feb. 24, No. 1. 7, 2007. Hamrin et al., “Gabapentin and Methylphenidate Treatment of a Preadolescent with Attention Deficit Hyperactivity Disorder and Bipolar Disorder.” Journal of Child and Adolescent (51) Int. Cl. Pychopharmacology, 2001, pp. 301-09, vol. 11, No. 3. A6 IK3I/4I66 (2006.01) Schreier, “Risperidone for Young Children with Mood Disorders and A6 IK3I/9 (2006.01) Aggressive Behavior.” Journal of Child and Adolescent A 6LX3L/95 (2006.01) Pychopharmacology, 1998, pp. 49-59, vol. 8, No. 1. A6 IK3I/35 (2006.01) (Continued) A6 IK3I/445 (2006.01) A6 IK3I/4458 (2006.01) A6 IK3I/53 (2006.01) Primary Examiner — Jennifer M Kim A6 IK3I/55 (2006.01) (74) Attorney, Agent, or Firm — Leydig, Voit & Mayer, Ltd. (52) U.S. Cl. (57) ABSTRACT CPC ............. A6 IK3I/19 (2013.01); A61 K3I/4166 A method is described for treating attention deficit hyperac (2013.01); A61 K31/195 (2013.01); A61 K tivity disorder (ADHD), by administering to the individual an 3 1/35 (2013.01); A61 K3I/445 (2013.01); anti-epileptic mood stabilizer at a dose which is sub-thera A6 IK3I/4458 (2013.01); A61 K3I/53 peutic for mood stabilization, optionally in combination with (2013.01); A61 K3I/55 (2013.01) a psychoStimulant. Also described is a method of improving USPC .......................................................... S14/391 reading comprehension and/or fluency in an individual Suf (58) Field of Classification Search fering from learning difficulties which method comprises CPC .................................................. A61K 31/4166 administering to the individual an anti-epileptic mood stabi USPC ......... 514/217,317,326,376, 386, 391,455, lizer. 514/557,561 See application file for complete search history. 2 Claims, No Drawings US 8,957,099 B2 Page 2 (56) References Cited Scheffer et al., Am. J. Psychiatry, 162(1): 58-64 (Jan. 2005). Silva et al., J. Am. Acad Child Adolesc. Psychiatry, 35(3): 352-358 OTHER PUBLICATIONS (Mar. 1996). Yitzchak, Clinical Electroencephalography, 24(1): 19-24 (1993). Davids et al., “A pilot clinical trial of oxcarbazepine in adults with Zaremba et al., Pharmacological Reports, 58: 1-12 (2008). Australian Patent Office, International Search Report in International attention deficit hyperactivity disorder.” Progress in Neuro Application No. PCT/AU2009/001000 (Oct. 6, 2009). Psychopharmacology & Biological Psychiatry, 2006, pp. 1033-1038, Australian Patent Office, International Search Report in International vol. 30. Application No. PCT/AU2008/000154 (Jun. 10, 2009). Baskys et al., Drug Development Research, 56: 393-400 (2002). Australian Patent Office, International Search Report in International Bernejo, Movement Disorders, 22(14): (2007). Application No. PCT/AU2007/00421 (Jun. 29, 2007). Chiu et al., Psychiatry and Clinical Neurosciences, 61: 630-633 United Kingdom Patent Office, Search Report in GB Patent Appli (2007). cation No. 1111712.4 (Oct. 11, 2011). Dhikav, Medical Hypotheses 67: 725-728 (2006). United Kingdom Patent Office, Search Report in GB Patent Appli Grunze, Dialogues Clin Neurosci., 10: 77-89 (2008). cation No. 1111712.4 (Feb. 10, 2012). Hill, Movement Disorders, 18(11): 1301-1371 (2003). Loy et al., Journal of Molecular Neuroscience, 19:303-307 (2002). Miyazaki et al., Brain and Development, 28: 470-472 (2006). Tekinet al., Journal of Neural Transmission, 105: 295-303 (1998). Reis et al. Bras Psiquiatr., 30(2): 132-135 (2008). Rogawski, Nature Medicine, 10(7), (Jul. 2004). * cited by examiner US 8,957,099 B2 1. 2 TREATMENT OF ADHD diagnostic groups. Until August 2005, the only stimulant available under the Australian Pharmaceutical Benefits FIELD AND BACKGROUND TO THE Scheme (PBS) was dexamphetamine, explaining its predomi INVENTION nant place in Australia for the treatment of ADHD. The PBS has since added methylphenidate to the Subsidised listing, the The present invention relates to the treatment of individuals most commonly used CNS stimulant in the US for the treat with attention-deficit hyperactivity disorder with an anti-epi ment of ADHD. leptic mood stabiliser (AEDMS), optionally in combination In both children and adolescents, stimulants can provide with psychoStimulants, for example to improve psychosocial robust improvement in ADHD behavioural symptoms. and cognitive function in Such individuals. The present inven 10 Despite this, there is continued functional impairment in tion also relates to the treatment of individuals with other patients. In adults this was particularly evident in the area DSM-IV-TR classified disorders, such as autistic spectrum which is often referred to as higher executive function. This disorders. The present invention further relates to the treat includes the ability to sequence, organise and integrate cog ment of learning difficulties, such as reading difficulties. nitive functioning and appears to be used during the complex Attention-deficit hyperactivity disorder (ADHD) is a 15 interpersonal interaction which forms the basis of human developmental disorder distinguished by symptoms of inat Social communication: any impairment in this area is quickly tention, hyperactivity and impulsivity (Snyder, Nussbaum, & detected by almost every individual although it may not be Robins (Eds.), 2006, Clinical Neuropsychology: A Pocket easily identified or described. The use of stimulant medica Handbook for Assessment, APABooks, Washington D.C.). tion enables a reduction in the motivation and effort required Although ADHD is one of the most frequently diagnosed to complete a task, but they do not appear to enable the psychological disorders in childhood long-term studies have individual to make the complex task easier with repeated demonstrated that symptoms can be maintained into adult exposure. Thus the inevitable fatigue that comes from this is hood. The number of children and adolescents who maintain not counterbalanced by improved efficiency and eventually ADHD symptoms and continue their treatment as adults the task is ceased. ranges from 36% to 65%. Data derived from longitudinal 25 This same model can be applied to social interaction. For studies suggest that although the symptom cluster of hyper example, we have noted that the tendency to hyper-focus on a activity and impulsivity decays over time, the symptoms of specific topic during conversation did not reduce consistently inattention persist and the proportion of clinically referred on stimulants alone, as it would appear that the individual adults with ADHD endorsing prominent inattentive symp could not process simultaneously the multiple lines of toms may be as high as 90%. Adult ADHD has now been 30 thought that usually take place in normal Social interaction. recognised as a valid clinical entity that is associated with Instead there would be the selection of a preferred more profound psychosocial and cognitive impairments (Weiss & comfortable, possibly more familiar topic and as conse Murray, 2003, CMAJ. 168(6): 715-22). quence, resistance to follow the natural flow of the conversa Studies of children and adults with ADHD indicate that tion. Thus providing sufficient motivation exists, conversa many experience an array of cognitive impairments that 35 tion can occur, but it still requires considerable effort and is extend beyond the behavioural symptoms outlined in the often observed by the listener as awkwardness during the diagnostic criteria for the disorder (DSM-IV-TR; American interaction and the individual will inevitably, in time, fatigue Psychiatric Association, 2000). Higher level cognitive and due to the effort involved. This results in a similar, although information processing impairments have been reported, the delayed, experience of mental exhaustion and failure to Sus functional day-to-day implications of which include chronic 40 tain attention that existed prior to the commencement of difficulties in maintaining alertness, self-discipline, estab stimulants. Thus, we have observed that unless there is an lishing and keeping routines, and completing tasks. Adults improvement in the ability to process information, the with ADHD change jobs more often, accrue more speeding improved motivation provided by the stimulant will inevita tickets and have more vehicle accidents than adults without bly wane.
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