Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Andrew Billnitzer, MD | UNKNOWN |
Not provided
Not provided
Not provided
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.
Tourette Syndrome is typically treated with drugs that block or reduce the function of dopamine (a brain chemical involved in movement). However, many of these drugs have adverse effects including irreversible, involuntary movements, typically affecting the face, known as tardive dyskinesia. Newer drugs may have lower risk of tardive dyskinesia. However, many of these drugs are still in clinical trials or are very expensive when used off-label (without FDA approval) to treat Tourette Syndrome. Given these limitations, exploring the potential of other drugs is essential in helping patients.
Several studies have shown that serotonin, another chemical in the brain like dopamine, may also play a role in the symptoms of Tourette Syndrome. Serotonin is already the target of many drugs in the treatment of depression, anxiety and obsessive-compulsive disorder which frequently occur in patients with Tourette Syndrome. Pimavanserin is also a drug that works on serotonin system. This means it may be helpful in the treatment of Tourette Syndrome.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pimavanserin | Experimental | All participants will receive pimavanserin 17mg once daily for 1 week and, if the tics are deemed to be inadequately controlled then increase to 34 mg once daily, taken orally as two 17 mg tablets once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimavanserin | Drug | Pimavanserin is a serotonin receptor inverse agonist used in treatment of psychosis in Parkinson's disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of pimavanserin on Tourette Syndrome | The primary objective is to evaluate the effect of pimavanserin on motor and phonic tics associated with Tourette Syndrome using the Yale Global Tic Severity Scale. The minimum score for this scale is 0 and the maximum score for this scale 100. A higher score suggests a more sever Tic or that the Tic has a greater impact on the person's life. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of pimavanserin on Tourette Syndrome | A secondary objective is to evaluate the effect of pimavanserin on obsessive-compulsive behaviors associated with Tourette Syndrome using the Yale-Brown Obsessive Compulsive Scale. The minimum score of this scale is 0 and the maximum score of this scale is 40. A higher score represents greater severity of obsessive compulsive symptoms. | 10 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21484868 | Background | Jankovic J, Kurlan R. Tourette syndrome: evolving concepts. Mov Disord. 2011 May;26(6):1149-56. doi: 10.1002/mds.23618. Epub 2011 Apr 11. | |
| 26918185 | Background | Thenganatt MA, Jankovic J. Recent Advances in Understanding and Managing Tourette Syndrome. F1000Res. 2016 Feb 9;5:F1000 Faculty Rev-152. doi: 10.12688/f1000research.7424.1. eCollection 2016. |
Not provided
Not provided
IPD will not be made available to other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2021 | Mar 1, 2021 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| D000071057 | Tardive Dyskinesia |
| D020323 | Tics |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C510793 | pimavanserin |
Not provided
Not provided
Not provided
This is an open-label, proof-of-principle, 8-week treatment, pilot study for male and female patients aged 18 years and older with Tourette Syndrome. There were no control groups nor randomization.
Not provided
Not provided
Not provided
Not provided
| Evaluate the effect of pimavanserin on Tourette Syndrome | A secondary objective is to evaluate the effect of pimavanserin on motor and phonic tics associated with Clinical Global Impression Scale. The minimum score of this scale is 1 and the maximum score of this scale is 7. A higher score suggests a more sever symptom. | 10 weeks |
| Evaluate the effect of pimavanserin on Tourette Syndrome | A secondary objective is to evaluate the effect of pimavanserin on motor and phonic tics associated with Patient Global Impression of Improvement Scale. The minimum score of this scale is 1 and the maximum score of this scale is 7. A higher score suggests symptoms are very much worse. | 10 weeks |
| Evaluate the effect of pimavanserin on Tourette Syndrome | A secondary objective is to evaluate the effect of pimavanserin on motor and phonic tics and obsessive-compulsive behaviors associated with Tourette Syndrome using the Columbia-Suicide Severity Rating Scale (C-SSRS). The minimum score of this scale is 2 and the maximum score of this scale is 25, with a higher score indicating more intense ideation and greater risk. | 10 weeks |
| Evaluate the effect of pimavanserin on Tourette Syndrome | A secondary objective is to evaluate the effect of pimavanserin on motor and phonic tics and obsessive-compulsive behaviors associated with Tourette Syndrome using the Gilles de la Tourette Syndrome Quality of Life Scale. The minimum score is 0 and the maximum score is 108, with a higher score indicating extreme problems. | 10 weeks |
| 32856174 | 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. |
| 28150698 | Background | Robertson MM, Eapen V, Singer HS, Martino D, Scharf JM, Paschou P, Roessner V, Woods DW, Hariz M, Mathews CA, Crncec R, Leckman JF. Gilles de la Tourette syndrome. Nat Rev Dis Primers. 2017 Feb 2;3:16097. doi: 10.1038/nrdp.2016.97. |
| 24295621 | Background | Paschou P, Fernandez TV, Sharp F, Heiman GA, Hoekstra PJ. Genetic susceptibility and neurotransmitters in Tourette syndrome. Int Rev Neurobiol. 2013;112:155-77. doi: 10.1016/B978-0-12-411546-0.00006-8. |
| 24295619 | Background | Udvardi PT, Nespoli E, Rizzo F, Hengerer B, Ludolph AG. Nondopaminergic neurotransmission in the pathophysiology of Tourette syndrome. Int Rev Neurobiol. 2013;112:95-130. doi: 10.1016/B978-0-12-411546-0.00004-4. |
| 27601976 | 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. |
| 2768151 | Background | Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015. |
| 2684084 | Background | Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007. |
| 18955683 | Background | Cavanna AE, Schrag A, Morley D, Orth M, Robertson MM, Joyce E, Critchley HD, Selai C. The Gilles de la Tourette syndrome-quality of life scale (GTS-QOL): development and validation. Neurology. 2008 Oct 28;71(18):1410-6. doi: 10.1212/01.wnl.0000327890.02893.61. |
| 24001701 | Background | Jeon S, Walkup JT, Woods DW, Peterson A, Piacentini J, Wilhelm S, Katsovich L, McGuire JF, Dziura J, Scahill L. Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods. Contemp Clin Trials. 2013 Nov;36(2):414-20. doi: 10.1016/j.cct.2013.08.012. Epub 2013 Aug 31. |
| 30152283 | Background | Rothenberger A, Roessner V. Psychopharmacotherapy of Obsessive-Compulsive Symptoms within the Framework of Tourette Syndrome. Curr Neuropharmacol. 2019;17(8):703-709. doi: 10.2174/1570159X16666180828095131. |
| 8227493 | Background | McDougle CJ, Goodman WK, Leckman JF, Barr LC, Heninger GR, Price LH. The efficacy of fluvoxamine in obsessive-compulsive disorder: effects of comorbid chronic tic disorder. J Clin Psychopharmacol. 1993 Oct;13(5):354-8. |
| 7766289 | 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. |
| 2389798 | Background | Comings DE. Blood serotonin and tryptophan in Tourette syndrome. Am J Med Genet. 1990 Aug;36(4):418-30. doi: 10.1002/ajmg.1320360410. |
| 11448084 | 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. |
| 12904968 | 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. |
| 17987065 | 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. |
| 16945163 | 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. |
| 18772048 | 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. |
| 18928414 | 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. |
| 23099282 | 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. |
| 18544005 | 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. |
| 27917309 | 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. |
| 10401479 | 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. |
| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D004409 | Dyskinesia, Drug-Induced |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |