Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults

Phase 3

Recruiting

• Conditions: Tourette Disorder

• Registration Number: NCT05615220
• Lead Sponsor: Emalex Biosciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

Inclusion Criteria:<br><br> - = 6 years of age<br><br> - = 18 kg (~ 40 lbs.)<br><br> - TD diagnosis and both motor and vocal tics that cause impairment with normal<br> routines<br><br> - Minimum score of 20 on the YGTSS-R Total Tic Score<br><br> - May not be taking any medications used to treat motor or vocal tics for at least 14<br> days prior to Baseline.<br><br> - Effective contraception during the study and 30 days after last study dose for<br> sexually active subjects<br><br>Exclusion Criteria:<br><br> - Previous exposure to ecopipam<br><br> - Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder,<br> schizophrenia, major depressive disorder)<br><br> - Unstable unstable medical illness or clinically significant lab abnormalities<br><br> - Risk of suicide<br><br> - Pregnant or lactating women<br><br> - Moderate to severe renal insufficiency<br><br> - Hepatic insufficiency<br><br> - Positive urine drug screen<br><br> - Unstable doses for drugs to treat anxiety, depression, Attention Deficit<br> Hyperactivity Disorder<br><br> - Certain medications that would lead to drug interactions<br><br> - Recent behavioral therapy

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Yale Global Tic Severity Scale (YGTSS)