Objective: Evaluate the effect of ecopipam in children and adolescents with TS on measures of attention deficit disorder (ADHD), anxiety disorders (ANX), obsessive-compulsive disorder (OCD) and depression in subgroups of patients with these comorbidities

Background: TS has a high prevalence of psychiatric comorbidities that may affect treatment decisions.  Ecopipam is a D1 receptor antagonist under investigation for TS.  In a 12 week phase IIb, randomized, double-blind, placebo-controlled trial, ecopipam improved the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) by 30% (p=0.01).  Headache (9.2%), fatigue (6.6%), somnolence (6.6%), insomnia (5.3%), and restlessness (5.3%) were the most common treatment-related adverse reactions. Of the subjects in the modified intention-to-treat (mITT) population, defined as all participants who received at least 1 dose and at least 1 postbaseline evaluation, 66% had one or more comorbidities of ADHD, ANX, OCD, depression.  This work examined the effect of ecopipam on serial measures of these comorbidities over the duration of the study.

Method: Data from the phase IIb included subjects aged >6 to <18 years with TS and a YGTSS-TTS ≥ 20 at screening.  ADHD, ANX, and OCD medications were permitted if dosage was stable for ≥4 weeks before screening and not prescribed for TS.  These scales were administrated at baseline, weeks 4, 6, 8 and 12: Swanson Nolan and Pelham (SNAP-IV) for ADHD, Pediatric Anxiety Rating Scale (PARS) for ANX, Child Yale-Brown Obsessive Scale (CY-BOCS) for OCD and Childrens Depression Rating Scale-Revised (CDRS-R) for depression.  All analyses were performed on the mITT population. A mixed model for repeated measures was used to assess changes in these scales comparing ecopipam to placebo over the study and for each comorbid subgroup.

Results: Serial measures of SNAP-IV (and all subscales), PARS, CY-BOCS, and CDRS-R all showed no statistically significant difference in change from baseline between ecopipam and placebo.  For the most frequent comorbidity, ADHD, the Conners, Inattention, Oppositional, Hyperactive, Aggressive, Academic, and Total scores for the ecopipam group all trended lower compared to the matched placebo group.

Conclusion: In the phase IIb trial of children with TS, ecopipam significantly reduced the YGTSS-TTS while not affecting measures of common psychiatric comorbidities.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-and-tolerability-of-ecopipam-in-tourette-syndrome-ts-with-psychiatric-comorbidities/