Ecopipam Treatment of Tourette Syndrome

NCT01244633 | Completed Phase 1 Results DMC

• 1 other identifier: PSY301
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

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.

Conditions

Tourette's Syndrome

Keywords

Tourette's; Ecopipam; Dopamine receptors; Efficacy; Safety; Adults

Outcome Measures

Primary Outcomes (1)

• Yale Global Tic Severity Score

  The Yale Global Tic Severity Score is a composite of subject reported severity of motor (range 0-25) and vocal (range 0-25) tics , as well as an impairment score (range 0-50). The outcome we are using is the Total Tic Severity score which is the sum of the motor and vocal tic severity scores (range 0-50). The higher the score on this scale, the more severe the symptoms. A positive drug effect is associated with a decrease from baseline.

  8 weeks

Secondary Outcomes (6)

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

  Every 7 days

• Hamilton Depression Scale

  Every 7 days

• Premonitory Urge for Tics Scale (PUTS-1)

  Every 7 days

• Clinician Global Impression - Improvement and Severity Scales (CGI)

  End of trial

• Safety Assessments

  Every 7 days

Study Arms (1)

Ecopipam

EXPERIMENTAL

Active treatment

Drug: Ecopipam

Interventions

Ecopipam DRUG

50 or 100 mg tablets given once per day for eight weeks

Also known as: SCH 39166, PSYRX 101

Ecopipam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Psyadon Pharma: lead

Study Sites (4)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Atlantic Neuroscience Institute Overlook Hospital

Summit, New Jersey, 07092, United States

Location

North Shore Hospital

Manhasset, New York, 11030, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Chipkin RE, Iorio LC, Coffin VL, McQuade RD, Berger JG, Barnett A. Pharmacological profile of SCH39166: a dopamine D1 selective benzonaphthazepine with potential antipsychotic activity. J Pharmacol Exp Ther. 1988 Dec;247(3):1093-102.

  PMID: 2905002 BACKGROUND

Related Links

• Link to Sponsor's Website

MeSH Terms

Conditions

Tourette Syndrome

Interventions

ecopipam

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

This was an open label study with no placebo control

Results Point of Contact

• Title: Dr. Richard Chipkin
• Organization: Psyadon Pharmaceuticals

rchipkin@psyadonrx.com

3019192020

Study Officials

• Donald Gilbert, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 19, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: September 29, 2015
• Results First Posted: September 29, 2015

Record last verified: 2015-06

Locations

US (4)