Ecopipam Treatment of Tourette Syndrome

Tourette's Syndrome Clinical Trial

Official title:

Ecopipam Treatment of Tourette Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244633
• Other study ID #: PSY301
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 17, 2010
• Last updated: August 27, 2015
• Start date: October 2010
• Est. completion date: July 2013

Study information

• Verified date: June 2015
• Source: Psyadon Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome
• Tourette's Syndrome

Intervention

Drug:
• Ecopipam
50 or 100 mg tablets given once per day for eight weeks

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	North Shore Hospital	Manhasset	New York
United States	Atlantic Neuroscience Institute Overlook Hospital	Summit	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Psyadon Pharma

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adult Attention Deficit/Hyperactivity Disorder (ADHD) Self-report Symptom Checklist (ASRS)	This is a standard measure of ADHD severity that is typically used in these types of clinical trials.	Every 7 days	No
Secondary	Hamilton Depression Scale	This is a measure of feelings of depression that the patient might have.	Every 7 days	No
Secondary	Premonitory Urge for Tics Scale (PUTS-1)	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.	Every 7 days	No
Secondary	Clinician Global Impression - Improvement and Severity Scales (CGI)	This is a measure of how the treating physician perceives the effectiveness of a drug treatment, and it is typically used in these types of clinical trials.	End of trial	No
Secondary	Safety Assessments	Patients will be evaluated for any adverse events, and they will have a variety of blood tests to examine if any changes occur.	Every 7 days	Yes
Secondary	Columbia Scale for Suicide Risk	This test monitors whether the patient has any feelings of committing self-harm. It is mandated by the FDA to include this scale in all clinical trials of new central nervous system drugs.	Every 7 days	Yes

External Links

•   Link to Sponsor's Website