Ecopipam Treatment of Tourette Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Yale Global Tic Severity Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Ecopipam
Active treatment
干预措施: Ecopipam (Drug)
结局指标
主要结局
Yale Global Tic Severity Score
时间窗: 8 weeks
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.
次要结局
- 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)
- Columbia Scale for Suicide Risk(Every 7 days)