Ecopipam Treatment of Tourette Syndrome

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Brief Title

Ecopipam Treatment of Tourette Syndrome

Official Title

Ecopipam Treatment of Tourette Syndrome

Brief Summary

      Tourette's Syndrome is a neurological disease characterized by verbal and motor tics. The
      currently available drug treatments are considered to be inadequate. This clinical trial is
      designed to test if ecopipam is effective for the treatment of Tourette's Syndrome in adults.
    

Detailed Description

      Tourette's Syndrome is a neurological disease characterized by verbal and motor tics.
      Although its causes are unknown, many researchers believe that changes in brain chemicals
      (called neurotransmitters) are critically involved. One of these neurotransmitters is called
      dopamine, and it exerts its actions through its receptors (called D1-type or D2-type). It has
      been suggested that the symptoms of Tourette's Syndrome are due to an overactivity at the
      D1-type receptor. Ecopipam is a selective antagonist of the D1-type receptors. The present
      clinical trial is designed to test if ecopipam is able to relieve the symptoms of the disease
      in adults patients with Tourette's Syndrome. Eligible patients will be treated for eight
      weeks.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Yale Global Tic Severity Score

Secondary Outcome

 Adult Attention Deficit/Hyperactivity Disorder (ADHD) Self-report Symptom Checklist (ASRS)

Condition

Tourette's Syndrome

Intervention

Ecopipam

Study Arms / Comparison Groups

 Ecopipam
Description:  Active treatment

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

18

Start Date

October 2010

Completion Date

July 2013

Primary Completion Date

July 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects must have TS (Tourette's Syndrome) based on the clinician-administered DCI
             (Diagnostic Confidence Index) for TS.

          -  Subjects must exhibit both motor and vocal tics.

          -  Subjects must have exhibited tics for >5 years.

          -  Subjects must have a minimum score of 20 at both Screening and Baseline (just prior to
             the first treatment) on the YGTSS (Yale Global Tic Severity Score).

          -  Subjects must be age ≥ 18 years.

          -  Women must be postmenopausal (> 12 months without menses) or surgically sterile (i.e.,
             by hysterectomy and/or bilateral oophorectomy) or 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. Women of childbearing potential must 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 must execute a written informed consent.

        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 (score of ≥ 2 on Item 3 for the
             Hamilton Depression Rating Scale [HAM-D])

          -  Subjects with a first-degree relative with a major depressive episode that resulted in
             any psychiatric hospitalization, attempted or completed suicide

          -  Subjects with a history of seizures.

          -  Subjects with a myocardial infarction within 6 months.

          -  Women of childbearing potential 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, naltrexone, methylphenidate, or psychostimulants),
             unfavorable interactions with ecopipam (ie, dopamine agonists [including bupropion]),
             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 Statistical Manual IV Text Revision (DSM-IV-TR) 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 or depot neuroleptics within 3 months

               -  fluoxetine within 6 weeks

               -  other psychotropics with possible effects on TS symptoms (ie, lithium, or
                  naltrexone) within 2 weeks prior to Screening.

               -  oral neuroleptics within 2 weeks

               -  selective serotonin reuptake inhibitors unless the dosage has been stable for a
                  minimum of 4 weeks prior to study start
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Donald Gilbert, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01244633

Organization ID

PSY301


Responsible Party

Sponsor

Study Sponsor

Psyadon Pharma


Study Sponsor

Donald Gilbert, MD, Principal Investigator, Children's Hospital Medical Center, Cincinnati


Verification Date

June 2015