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

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Brief Title

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

Official Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Yale Global Tic Severity Scale

Secondary Outcome

 Safety

Condition

Tourette's Syndrome

Intervention

Ecopipam

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

March 2014

Completion Date

December 2019

Primary Completion Date

December 2019

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.

          -  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
      

Gender

All

Ages

7 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Donald Gilbert, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02102698

Organization ID

PSY302


Responsible Party

Sponsor

Study Sponsor

Psyadon Pharma


Study Sponsor

Donald Gilbert, MD, Study Chair, Children's Hospital Medical Center, Cincinnati


Verification Date

November 2016