Adults 6 to 17, any sex, with Tourette Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12Primary· Baseline, Week 12
The YGTSS was a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were made along 5 different dimensions on a scale of 0=none to 5=severe for motor and vocal tics, each including number, frequency, intensity, complexity, and interference. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The total tic score (TTS) ranged from 0 (none) to 50 (severe) with higher score represent more severe symptoms. A nega
Group
Value
95% CI
Ecopipam HCI 2 mg/kg/Day
-9.87
± 1.062
Placebo
-6.42
± 1.006
Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12Secondary· Baseline, Week 12
Clinical Global Impression (CGI) scale was used to assess overall severity on a 7-point Likert scale consisted of 2 reliable and valid 7-item Likert scales used to assess severity and change in clinical symptoms. The CGI severity scale ranges from 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill subject. 1 = "normal, not ill at all" to 7 = "extremely ill." A negative change indicates improvement in the condition.
Group
Value
95% CI
Ecopipam HCI 2 mg/kg/Day
-0.91
± 0.141
Placebo
-0.53
± 0.130
Adverse events — posted to ClinicalTrials.gov
Time frame: Screening up to 30 days after the last dose ( up to Week 16).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study evaluates the effect of ecopipam tablets in children and adolescents in the treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam tablets, while the other half will receive matching placebo tablets
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06194864 — Drug Interaction Study
· Phase 1
· completed
NCT05334108 — Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug
· Phase 1
· completed
NCT04492956 — Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)
· Phase 2
· completed
NCT04114539 — Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension
· Phase 2
· completed
NCT03218969 — Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
· Phase 1, PHASE2
· unknown
Other recruiting trials for Tourette Syndrome
Currently open trials in the same condition.
NCT07203469 — Where Wild Things Grow: Nature- and Activity-based Group Interventions for Neurodivergent Children and Youth
· NA
· recruiting
NCT06679790 — Trajectories of Change in Tourette Syndrome
· NA
· recruiting
NCT06909656 — Multimodal Electrophysiological Study of Cortico-subcortical Biomarkers of Tics in Tourette Syndrome
· NA
· recruiting
NCT06785532 — Effect of RNS in Treatment-refractory Tourette's Syndrome
· NA
· recruiting
Other Emalex Biosciences Inc. trials
Trials by the same sponsor.
NCT06669091 — Food-effect Study of Ecopipam Pharmacokinetics
· Phase 1
· completed
NCT06194864 — Drug Interaction Study
· Phase 1
· completed
NCT05841160 — Thorough QT/QTc Study to Evaluate the Effects of Ecopipam (EBS-101) on Cardiac Repolarization
· Phase 1
· completed
NCT05615220 — Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
· Phase 3
· completed
NCT05334108 — Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emalex Biosciences Inc.
Last refreshed: 4 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04007991.