Ecopipam Treatment of Tourette Syndrome

This study has been terminated.
(Interim analysis showed positive effects)
Sponsor:
Information provided by (Responsible Party):
Psyadon Pharma
ClinicalTrials.gov Identifier:
NCT01244633
First received: November 17, 2010
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Tourette's Syndrome
Drug: Ecopipam
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ecopipam Treatment of Tourette Syndrome

Resource links provided by NLM:


Further study details as provided by Psyadon Pharma:

Primary Outcome Measures:
  • Yale Global Tic Severity Score [ Time Frame: Every 7 days ] [ Designated as safety issue: No ]
    The Yale Global Tic Severity Score is the standard measure for effectiveness used in this type of clinical trial.


Secondary Outcome Measures:
  • Adult attention deficit/hyperactivity disorder (ADHD) self-report symptom checklist (ASRS) [ Time Frame: Every 7 days ] [ Designated as safety issue: No ]
    This is a standard measure of ADHD severity that is typcially used in these types of clinical trials.

  • Hamilton Depression Scale [ Time Frame: Every 7 days ] [ Designated as safety issue: No ]
    This is a measure of feelings of depression that the patient might have.

  • Premonitory Urge for Tics Scale (PUTS-1) [ Time Frame: Every 7 days ] [ Designated as safety issue: No ]
    This is a measure of the tic behavior that is seen in Tourette's patients, and it is typically used in these types of trials.

  • Clinician Global Impression - Improvement and Severity Scales (CGI) [ Time Frame: End of trial ] [ Designated as safety issue: No ]
    This is a measure of how the treating physicain perceives the effectiveness of a drug treatment, and it is typically used in these types of clinical trials.

  • Safety Assessments [ Time Frame: Every 7 days ] [ Designated as safety issue: Yes ]
    Patients will be evaluated for any adverse events, and they will have a variety of blood tests to examine if any changes occur.

  • Columbia Scale for Suicide Risk [ Time Frame: Every 7 days ] [ Designated as safety issue: Yes ]
    This test monitors whether the patient has any feelings of commiting self-harm. It is mandated by the FDA to include this scale in all clinical trials of new central nervous system drugs.


Enrollment: 18
Study Start Date: October 2010
Study Completion Date: July 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ecopipam
Active treatment
Drug: Ecopipam
50 or 100 mg tablets given once per day for eight weeks
Other Names:
  • SCH 39166
  • PSYRX 101

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have TS based on the clinician-administered DCI 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.
  • Subjects must be age ≥ 18 years.
  • Women must be postmenopausal (> 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, 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 (ie, 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 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 (ie, 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
  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: NCT01244633

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, New Jersey
Atlantic Neuroscience Institute Overlook Hospital
Summit, New Jersey, United States, 07092
United States, New York
North Shore Hospital
Manhasset, New York, United States, 11030
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Psyadon Pharma
Investigators
Principal Investigator: Donald Gilbert, MD Children's Hospital Medical Center, Cincinnati
  More Information

Additional Information:
Publications:
Responsible Party: Psyadon Pharma
ClinicalTrials.gov Identifier: NCT01244633     History of Changes
Other Study ID Numbers: PSY301
Study First Received: November 17, 2010
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Psyadon Pharma:
Tourette's
Ecopipam
Dopamine receptors
Efficacy
Safety
Adults

Additional relevant MeSH terms:
Tourette Syndrome
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
Mental Disorders Diagnosed in Childhood
Mental Disorders
Sch 39166
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 22, 2014