Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension (D1AMOND Trial)

Phase 2

Waitlist Available

Research Sponsored by Emalex Biosciences Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Subjects must have completed the EBS-101-CL-001 study through the Day 14 Follow Up Visit within the last 30 days (or longer with permission of the medical monitor) without a major reportable protocol deviation and must be someone the Investigator feels would benefit from continued participation.

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 1, 3, 6, 9 and 12

Awards & highlights

No Placebo-Only Group

Summary

This trial tested the safety of ecopipam tablets for children and adolescents with Tourette Syndrome. The medication aims to help manage their symptoms by affecting brain chemicals. Participants took the medication for an extended period with frequent check-ups. Ecopipam has shown promise in previous studies.

Eligible Conditions

Tourette Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 1, 3, 6, 9 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 1, 3, 6, 9 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1, 3, 6, 9 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Electrocardiogram (ECG) Values Parameters: Aggregate PR Interval, Aggregate QRS Duration, Aggregate QT Interval, and Aggregate QTc Interval

Change From Baseline in Hematology Parameters: Basophils to Leukocytes Ratio Reported in Percentage of Cells

Change From Baseline in Hematology Parameters: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells

+19 more

Secondary study objectives

Change From Baseline in Clinical Global Impression of Tourette Syndrome of Severity (CGI-TS-S) at Months 1, 3, 6, 9, 12

Change From Baseline in Gilles de la Tourette Syndrome-Quality of Life Scale for Children and Adolescents (C&A-GTS-QOL) Total Score at Months 1, 3, 6, 9 and 12

Change From Baseline in the Yale Global Tic Severity Scale - Global Score (YGTSS-GS) at Months 1, 3, 6, 9 and 12

+3 more