Ecopipam Treatment of Tourette's Syndrome in Subjects 7-17 Years

Emalex Biosciences Inc.11 sites in 1 country40 target enrollmentMarch 2014

ConditionsTourette's Syndrome

InterventionsEcopipam

DrugsEcopipam

Overview

Phase: Phase 2
Intervention: Ecopipam
Conditions: Tourette's Syndrome
Sponsor: Emalex Biosciences Inc.
Enrollment: 40
Locations: 11
Primary Endpoint: Yale Global Tic Severity Scale
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Tourette's Syndrome is a neurological disease characterized by motor and vocal tics. It has been hypothesized that abnormal interactions of dopamine with its receptors may cause the tics. The purpose of this study is to test the hypothesis that a drug (ecopipam) that selectively blocks dopamine D1/D5 receptors can reduce the frequency and severity of the tics.

Detailed Description

This is a double blind, randomized, placebo-controlled crossover study to determine whether ecopipam can reduce the symptoms of Tourette's in children age 7-17 years.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

December 2019

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Emalex Biosciences Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must have Tourette's Syndrome (TS) based on the clinician-administered Diagnostic Confidence Index (DCI) for TS.
•Subjects must exhibit both motor and vocal tics.
•Subjects must have a minimum score of 20 at both Screening and Baseline (just prior to the first treatment) on the Yale Global Tic Severity Scale.
•Subjects must be age (≥ 7 to \< 18 years of age)
•Subjects must weigh ≥ 20 kg (45 lbs)
•Adolescent females of childbearing potential who are sexually active must be using effective contraception (i.e., oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for the duration of their participation in the study. They must also agree to use contraception for 30 days after their last dose of study drug.
•Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.
•Subject's parent or legal guardian must execute a written informed consent.
•Subject must execute a written informed assent.

Exclusion Criteria

•Subjects who have unstable medical illness or clinically significant abnormalities on laboratory tests, or ECG at Screening.
•Subjects with a major depressive episode in the past 2 years
•Subjects with a history of attempted suicide
•Subjects with clinically significant suicidality (based on the Columbia Suicide Rating Scale (C-SSRS)
•Subjects with a first-degree relative with a major depressive episode that resulted in any psychiatric hospitalization, or attempted/ completed suicide with the exception of a hospitalization for post-partum depression.
•Subjects with a history of seizures (excluding febrile seizures that occurred \>2 years in the past)
•Subjects with a myocardial infarction within 6 months.
•Girls who are currently pregnant or lactating.
•Subjects who have a need for medication (other than ecopipam) with possible effects on TS symptoms (i.e., lithium, psychostimulants)
•Subjects who have a need for medications which would have unfavorable interactions with ecopipam, e.g., dopamine antagonists or agonists \[including bupropion\], tetrabenazine, or monoamine oxidase inhibitors.

Arms & Interventions

Ecopipam

Ecopipam is a selective antagonist of the dopamine D1/D5 receptor family that is being studied as a treatment for Tourette's Syndrome

Intervention: Ecopipam

Placebo

Placebo is the inactive comparator

Intervention: Ecopipam

Outcomes

Primary Outcomes

Yale Global Tic Severity Scale

Time Frame: 30 days

The Yale Global Tic Severity Scale (YGTSS) is the standard rating scale used to assess the effects of a new treatment on the symptoms of Tourette's Syndrome.

Secondary Outcomes

Adverse events (SAE), clinical laboratory values, regular measurement of vital signs, electrocardiograms, C-SSRS, Children's Depression Inventory and Physical Exams.(30 days)
Child Yale-Brown Obsessive Compulsive Scale(30 days)
Columbia-Suicide Severity Rating Scale(30 days)
DuPaul ADHD rating scale-IV(30 days)
Clinical Global Impression - Improvement and Severity Scales(30 days)
Children's Depression Inventory(30 days)