Objective: To determine whether pimavanserin has an effect on motor and behavioral aspects of Tourette syndrome (TS).

Background: Pimavanserin is a serotonin 2A receptor inverse agonist and antagonist approved by Food and Drug Administration (FDA) for treatment of hallucinations and delusions in Parkinson’s disease psychosis (1). Numerous studies support a role of serotonin in modulating TS symptoms and the co-morbid obsessive-compulsive behavior(2,3).

Method: In this open-label study of patients, 18 years or older with TS, pimavanserin was titrated to 34 mg/day over 1 week. Participants continued taking this dose for an additional 7 weeks. There was a 2 week washout at the end of the study. Tic severity, the primary outcome measure, was assessed by the Yale Global Tic Severity Scale Total Tic Severity score (TTS). Secondary outcome measures included changes in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), the Tourette Syndrome Clinical Global Impression of Change (TS-CGIC), the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII), and the Gilles de la Tourette Syndrome – Quality of Life scale (GTS-QOL). Measures were administered at baseline and at weeks 2, 4, 8 and 9.

Results: We enrolled 12 patients, but 2 dropped out after week 2due to side effects of drowsiness and weight gain.  In the 10 patients (mean standard deviation (SD) age 34 (12.9)) who completed the study the mean (SD) baseline TTS was 34 (9.3). This decreased by 3.6 (4.9) points at week 8, a 12% reduction in tic severity (p=0.03). This small improvement may not be clinically important. There was a non-significant improvement in YBOCS (mean (SD) -5.4 (8.4). All 10 patients reported improvement in the GTS-QOL, average improvement 17.1 (15.4). No serious adverse events were reported in the patients who completed the study.

Conclusion: The results of this pilot, open label, study suggest that pimavanserin is a safe treatment and associated with improvement in both objective and subjective measures symptoms in TS and its behavioral co-morbidities. These encouraging findings warrant further studies by a larger, placebo-controlled trial.

References: 1. Touma KTB, Touma DC. Pimavanserin (NuplazidTM) for the treatment of Parkinson disease psychosis: A review of the literature. Ment Heal Clin. 2017 Sep 1;7(5):230–4. 2. Forde NJ, Kanaan AS, Widomska J, Padmanabhuni SS, Nespoli E, Alexander J, et al. 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). 3. Rothenberger A, Roessner V. Psychopharmacotherapy of obsessive-compulsive symptoms within the framework of Tourette syndrome. Curr Neuropharmacol. 2018 Aug 28;17(8):703–9.

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