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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Psyadon Pharma
ClinicalTrials.gov Identifier:
NCT02102698
First received: March 31, 2014
Last updated: November 2, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Tourette's Syndrome
Drug: Ecopipam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ecopipam Treatment of Tourette's Syndrome in Subjects 7-17 Years

Resource links provided by NLM:


Further study details as provided by Psyadon Pharma:

Primary Outcome Measures:
  • Yale Global Tic Severity Scale [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The Columbia Suicide Severity Rating Scale is a validated rating scale which measures feelings of suicide.


Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   7 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102698

Locations
United States, California
UCLA
Los Angeles, California, United States, 90024
United States, Florida
University of South Florida/Rothman Center for Neuropsychiatry
St. Petersburg, Florida, United States, 33701
United States, Georgia
Emory University School Of Medicine
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago Medical School
Chicago, Illinois, United States, 60637
United States, Kansas
Children's Mercy Kansas City
Kansas City, Kansas, United States, 64108
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New York
North Shore-Long Island Jewish Hosptial
Manhasset, New York, United States, 11030
Weill Cornell Medical School
New York City, New York, United States, 10065
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45228
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Psyadon Pharma
Investigators
Study Chair: Donald Gilbert, MD Children's Hospital Medical Center, Cincinnati
  More Information

Publications:
Responsible Party: Psyadon Pharma
ClinicalTrials.gov Identifier: NCT02102698     History of Changes
Other Study ID Numbers: PSY302 
Study First Received: March 31, 2014
Last Updated: November 2, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Psyadon Pharma:
Tourette's Syndrome
Ecopipam
D1 Receptor
Phase 2

Additional relevant MeSH terms:
Syndrome
Tourette Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Ecopipam
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 08, 2016