Pimavanserin Treatment in TS

Summary

This research study is determining if a drug called Pimavanserin if safe and effective in the treatment of the symptoms of Tourette Syndrome. Pimavanserin is an investigational drug for Tourette Syndrome, which means it has not been approved by the United States Food and Drug Administration (FDA) to treat Tourette Syndrome. Pimavanserin has been approved by the FDA as a treatment for hallucinations in Parkinson's Disease. It is currently marketed under the name NUPLAZID (pimavanserin) capsules by Acadia Pharmaceuticals.

Timeline

Start

2018-11-12

Primary completion

2021-02-28

Completion

2021-02-28

Publications

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• Background Billnitzer A, Jankovic J. Current Management of Tics and Tourette Syndrome: Behavioral, Pharmacologic, and Surgical Treatments. Neurotherapeutics. 2020 Oct;17(4):1681-1693. doi: 10.1007/s13311-020-00914-6.
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• Background Forde NJ, Kanaan AS, Widomska J, Padmanabhuni SS, Nespoli E, Alexander J, Rodriguez Arranz JI, Fan S, Houssari R, Nawaz MS, Rizzo F, Pagliaroli L, Zilhao NR, Aranyi T, Barta C, Boeckers TM, Boomsma DI, Buisman WR, Buitelaar JK, Cath D, Dietrich A, Driessen N, Drineas P, Dunlap M, Gerasch S, Glennon J, Hengerer B, van den Heuvel OA, Jespersgaard C, Moller HE, Muller-Vahl KR, Openneer TJ, Poelmans G, Pouwels PJ, Scharf JM, Stefansson H, Tumer Z, Veltman DJ, van der Werf YD, Hoekstra PJ, Ludolph A, Paschou P. TS-EUROTRAIN: A European-Wide Investigation and Training Network on the Etiology and Pathophysiology of Gilles de la Tourette Syndrome. Front Neurosci. 2016 Aug 23;10:384. doi: 10.3389/fnins.2016.00384. eCollection 2016.
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• Background Leckman JF, Goodman WK, Anderson GM, Riddle MA, Chappell PB, McSwiggan-Hardin MT, McDougle CJ, Scahill LD, Ort SI, Pauls DL, et al. Cerebrospinal fluid biogenic amines in obsessive compulsive disorder, Tourette's syndrome, and healthy controls. Neuropsychopharmacology. 1995 Feb;12(1):73-86. doi: 10.1038/sj.npp.1380241.
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• Background Cath DC, Spinhoven P, Landman AD, van Kempen GM. Psychopathology and personality characteristics in relation to blood serotonin in Tourette's syndrome and obsessive-compulsive disorder. J Psychopharmacol. 2001 Jun;15(2):111-9. doi: 10.1177/026988110101500208.
• Background Higgins GA, Enderlin M, Haman M, Fletcher PJ. The 5-HT2A receptor antagonist M100,907 attenuates motor and 'impulsive-type' behaviours produced by NMDA receptor antagonism. Psychopharmacology (Berl). 2003 Nov;170(3):309-319. doi: 10.1007/s00213-003-1549-0. Epub 2003 Aug 7.
• Background Wong DF, Brasic JR, Singer HS, Schretlen DJ, Kuwabara H, Zhou Y, Nandi A, Maris MA, Alexander M, Ye W, Rousset O, Kumar A, Szabo Z, Gjedde A, Grace AA. Mechanisms of dopaminergic and serotonergic neurotransmission in Tourette syndrome: clues from an in vivo neurochemistry study with PET. Neuropsychopharmacology. 2008 May;33(6):1239-51. doi: 10.1038/sj.npp.1301528. Epub 2007 Nov 7.
• Background Haugbol S, Pinborg LH, Regeur L, Hansen ES, Bolwig TG, Nielsen FA, Svarer C, Skovgaard LT, Knudsen GM. Cerebral 5-HT2A receptor binding is increased in patients with Tourette's syndrome. Int J Neuropsychopharmacol. 2007 Apr;10(2):245-52. doi: 10.1017/S1461145706006559. Epub 2006 Feb 28.
• Background Steeves TD, Fox SH. Neurobiological basis of serotonin-dopamine antagonists in the treatment of Gilles de la Tourette syndrome. Prog Brain Res. 2008;172:495-513. doi: 10.1016/S0079-6123(08)00924-2.
• Background McCracken JT, Suddath R, Chang S, Thakur S, Piacentini J. Effectiveness and tolerability of open label olanzapine in children and adolescents with Tourette syndrome. J Child Adolesc Psychopharmacol. 2008 Oct;18(5):501-8. doi: 10.1089/cap.2007.135.
• Background Weisman H, Qureshi IA, Leckman JF, Scahill L, Bloch MH. Systematic review: pharmacological treatment of tic disorders--efficacy of antipsychotic and alpha-2 adrenergic agonist agents. Neurosci Biobehav Rev. 2013 Jul;37(6):1162-71. doi: 10.1016/j.neubiorev.2012.09.008. Epub 2012 Oct 23.
• Background Porta M, Sassi M, Cavallazzi M, Fornari M, Brambilla A, Servello D. Tourette's syndrome and role of tetrabenazine: review and personal experience. Clin Drug Investig. 2008;28(7):443-59. doi: 10.2165/00044011-200828070-00006.
• Background Jankovic J, Jimenez-Shahed J, Budman C, Coffey B, Murphy T, Shprecher D, Stamler D. Deutetrabenazine in Tics Associated with Tourette Syndrome. Tremor Other Hyperkinet Mov (N Y). 2016 Nov 7;6:422. doi: 10.7916/D8M32W3H. eCollection 2016.
• Background Bonnier C, Nassogne MC, Evrard P. Ketanserin treatment of Tourette's syndrome in children. Am J Psychiatry. 1999 Jul;156(7):1122-3. doi: 10.1176/ajp.156.7.1122a. No abstract available.

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Indications