Abstract Details

Title Safety and Tolerability of Ecopipam in Tourette Syndrome with Psychiatric Comorbidities

Topic Movement Disorders

Presentation(s) P10 - Poster Session 10 (11:45 AM-12:45 PM)

Poster/Presentation
Number 3-001

Objective To evaluate the effect of ecopipam in treating children and adolescents with Tourette Syndrome (TS) on measures of attention-deficit hyperactivity disorder (ADHD), anxiety disorders (ANX), obsessive-compulsive disorder (OCD) and depression.

Background Tourette syndrome (TS) has a high prevalence of psychiatric comorbidities that may affect treatment decisions. Ecopipam is a first-in-class D1 receptor antagonist under investigation for TS. In a 12 week phase IIb, randomized, double-blind, placebo-controlled trial (D1AMOND), ecopipam improved the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) (p=0.01). Headache (9.2%), fatigue (6.6%), somnolence (6.6%), insomnia (5.3%), and restlessness (5.3%) were the most common adverse reactions. Of the subjects enrolled, 63% had one or more comorbidities of ADHD, ANX, and OCD. This work examined the effect of ecopipam on serial measures of these comorbidities.

Design/Methods 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. The following scales were administrated at baseline, weeks 4, 6, 8 and 12: Swanson, Nolan, and Pelham-IV (SNAP-IV) for ADHD, Pediatric Anxiety Rating Scale (PARS) for ANX, Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for OCD and Children's Depression Rating Scale-Revised (CDRS-R) for depression. A mixed model for repeated measures was used to assess changes in these scales.

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.

Conclusions In the D1AMOND trial of children and adolescents with TS, ecopipam significantly reduced the YGTSS-TTS while not affecting measures of common psychiatric comorbidities.

Authors/Disclosures
Donald Gilbert, MD, FAAN (Cincinnati Children's Hospital Med. Ctr.) PRESENTER	Dr. Gilbert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PTC Therapeutics. Dr. Gilbert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Illumina. Dr. Gilbert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Emalex Biosciences. The institution of Dr. Gilbert has received research support from NIMH. The institution of Dr. Gilbert has received research support from Emalex Biosciences. The institution of Dr. Gilbert has received research support from PTC Therapeutics. The institution of Dr. Gilbert has received research support from Department of Defense. The institution of Dr. Gilbert has received research support from Quince Therapeutics. Dr. Gilbert has received publishing royalties from a publication relating to health care. Dr. Gilbert has received publishing royalties from a publication relating to health care. Dr. Gilbert has received personal compensation in the range of $500-$4,999 for serving as a Medical Second Opinion Expert with Teldoc/Advanced Medical. Dr. Gilbert has received personal compensation in the range of $10,000-$49,999 for serving as a Medical Expert with Department of Health and Human Services/Vaccine Injury Compensation Program.
Timothy Cunniff, PharmD	Dr. Cunniff has received personal compensation for serving as an employee of Paragon Biosciences. Dr. Cunniff has stock in Harmony Biosciences. Dr. Cunniff has stock in Emalex Biosciences.
Frederick E. Munschauer III, MD, FAAN (FEMC)	Dr. Munschauer has received personal compensation for serving as an employee of Emalex Biosciences. Dr. Munschauer has stock in Emalex Biosciences.
George Karkanias, PhD (Emalex Biosciences, Inc.)	Dr. Karkanias has received personal compensation for serving as an employee of Emalex Biosciences, Inc.
Sarah Atkinson (Emalex Biosciences)	Sarah Atkinson has received personal compensation for serving as an employee of Emalex Biosciences. Sarah Atkinson has received personal compensation for serving as an employee of World Wide Clinical Trials.
Stephen Wanaski, PhD (Paragon Biosciences)	Dr. Wanaski has received personal compensation for serving as an employee of Paragon Biosciences. Dr. Wanaski has or had stock in Paragon Biosciences.Dr. Wanaski has or had stock in Emalex Biosciences.

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