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

Tourette's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102698
• Other study ID #: PSY302
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: December 2019

Study information

• Verified date: November 2016
• Source: Emalex Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.

• Subjects with a lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) Axis-I Disorders (SCID).

• Subjects with current or recent (past 3 months) DSM-IV substance abuse or dependence (with the exception of nicotine).

• Subjects with positive urine drug screen (cocaine, amphetamine, methamphetamine, tetrahydrocannabinol (THC), benzodiazepines, barbiturates, phencyclidine (PCP), opiates) at Screening. Subjects with urine positive only for benzodiazepines and/or marijuana (i.e., a user but not an abuser as based on DSM-IV criteria) may be eligible.

• Subjects who have had previous treatment with ecopipam.

• Subjects who have had treatment with:

• investigational medication within 3 months of starting study

• depot neuroleptics within 3 months of starting study

• other psychotropics with possible effects on TS symptoms (i.e., lithium, tetrabenazine) within 2 weeks prior to Screening.

• oral neuroleptics within 4 weeks

• selective serotonin reuptake inhibitors unless the dosage has been stable for a minimum of 4 weeks prior to study start and not prescribed to relieve the neurological signs of TS

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome
• Tourette's Syndrome

Intervention

Drug:
• Ecopipam
Ecopipam is a selective antagonist of the dopamine D1 receptor family.

Locations

Country	Name	City	State
United States	Emory University School Of Medicine	Atlanta	Georgia
United States	University of Chicago Medical School	Chicago	Illinois
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	Children's Mercy Kansas City	Kansas City	Kansas
United States	UCLA	Los Angeles	California
United States	North Shore-Long Island Jewish Hosptial	Manhasset	New York
United States	Weill Cornell Medical School	New York	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of South Florida/Rothman Center for Neuropsychiatry	Saint Petersburg	Florida
United States	Overlook Hospital	Summit	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Emalex Biosciences Inc.	Psyadon Pharma

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gilbert DL, Budman CL, Singer HS, Kurlan R, Chipkin RE. A D1 receptor antagonist, ecopipam, for treatment of tics in Tourette syndrome. Clin Neuropharmacol. 2014 Jan-Feb;37(1):26-30. doi: 10.1097/WNF.0000000000000017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Global Tic Severity Scale	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.	30 days
Secondary	Adverse events (SAE), clinical laboratory values, regular measurement of vital signs, electrocardiograms, C-SSRS, Children's Depression Inventory and Physical Exams.	Safety evaluations are included.	30 days
Secondary	DuPaul ADHD rating scale-IV	This is a validated rating scale for the symptoms of attention deficit disorder. This is included because people with Tourette's often have attention deficit hyperactivity disorder (ADHD) as well.	30 days
Secondary	Child Yale-Brown Obsessive Compulsive Scale	This is validated rating scale which measures symptoms of obsessive-compulsive behaviors. People with Tourette's often also show symptoms of obsessive-compulsive behaviors.	30 days
Secondary	Children's Depression Inventory	The Children's Depression Inventory is a validate rating scale which measures signs of depression of in children. People with Tourette's often report feelings of depression. In addition, treatment with ecopipam has been reported to increase signs of depression in some patients.	30 days
Secondary	Clinical Global Impression - Improvement and Severity Scales	Clinical Global Impression Scales (improvement and severity) are validated rating scales that measure whether the treatment improves the symptoms of the disease (CGI-I) and whether the treatment reduces the severity of the disease (CGI-S)	30 days
Secondary	Columbia-Suicide Severity Rating Scale	The Columbia Suicide Severity Rating Scale is a validated rating scale which measures feelings of suicide.	30 days