Phase 2
N=153
Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents
Tourette Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04007991 ↗Enrolled (actual)
153
Serious AEs
2.0%
Results posted
Oct 2023
Primary outcome: Primary: Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12 — -9.87; -6.42 score on a scale — p==0.011
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ecopipam (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Emalex Biosciences Inc.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12 |
-9.87; -6.42 | =0.011 sig |
| SECONDARY Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12 |
-0.91; -0.53 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- ≥ 6 and < 18 years of age
- ≥ 18 kg (~ 40 lbs.)
- TS diagnosis and both motor and vocal tics that cause impairment with normal routines
- Minimum score of 20 on the YGTSS-Total Tic Score
- May not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline.
- Effective contraception during the study and 30 days after last study dose for sexually active subjects
Exclusion Criteria
- Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder)
- Unstable medical illness or clinically significant lab abnormalities
- Risk of suicide
- Pregnant or lactating women
- Moderate to severe renal insufficiency
- Hepatic insufficiency
- Positive urine drug screen
- Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity Disorder
- Certain medications that would lead to drug interactions
- Recent behavioral therapy
Data sourced from ClinicalTrials.gov (NCT04007991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.