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

Sponsor

Psyadon Pharma (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02102698

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

3.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tourette's Syndrome	Drug: Ecopipam	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ecopipam Ecopipam is a selective antagonist of the dopamine D1/D5 receptor family that is being studied as a treatment for Tourette's Syndrome	Drug: Ecopipam Ecopipam is a selective antagonist of the dopamine D1 receptor family. Other Names: SCH 39166 PSYRX101
Placebo Comparator: Placebo Placebo is the inactive comparator	Drug: Ecopipam Ecopipam is a selective antagonist of the dopamine D1 receptor family. Other Names: SCH 39166 PSYRX101

Arm

Intervention/Treatment

Experimental: Ecopipam

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

Drug: Ecopipam

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

Other Names:

SCH 39166

PSYRX101

Placebo Comparator: Placebo

Placebo is the inactive comparator

Drug: Ecopipam

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

Other Names:

SCH 39166

PSYRX101

Outcome Measures

Primary Outcome Measures

Yale Global Tic Severity Scale [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 Outcome Measures

Safety [30 days]
Safety will be assessed by monitoring and recording all Adverse Events (AE) and serious adverse events (SAE), regular monitoring of hematology, blood chemistry, and urine values, regular measurement of vital signs and the performance of a physical examination and an ECG
DuPaul ADHD rating scale-IV [30 days]
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.
Child Yale-Brown Obsessive Compulsive Scale [30 days]
This is validated rating scale which measures symptoms of obsessive-compulsive behaviors. People with Tourette's often also show symptoms of obsessive-compulsive behaviors.
Children's Depression Inventory [30 days]
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.
Clinical Global Impression - Improvement and Severity Scales [30 days]
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)
Columbia-Suicide Severity Rating Scale [30 days]
The Columbia Suicide Severity Rating Scale is a validated rating scale which measures feelings of suicide.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90024
2	University of South Florida/Rothman Center for Neuropsychiatry	St. Petersburg	Florida	United States	33701
3	Emory University School Of Medicine	Atlanta	Georgia	United States	30322
4	University of Chicago Medical School	Chicago	Illinois	United States	60637
5	Children's Mercy Kansas City	Kansas City	Kansas	United States	64108
6	Washington University School of Medicine	St. Louis	Missouri	United States	63110
7	Overlook Hospital	Summit	New Jersey	United States	07902
8	North Shore-Long Island Jewish Hosptial	Manhasset	New York	United States	11030
9	Weill Cornell Medical School	New York City	New York	United States	10065
10	Cincinnati Children's Hospital	Cincinnati	Ohio	United States	45228
11	Baylor College of Medicine	Houston	Texas	United States	77030