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临床试验/EUCTR2019-000281-37-PL
EUCTR2019-000281-37-PL进行中（未招募）1 期

A Multicenter, Placebo-Controlled, Double-Blind, Randomized, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Ecopipam Tablets in Children and Adolescent Subjects with Tourette’s Syndrome - Diamond

Emalex Biosciences, Inc.0 个研究点目标入组 150 人开始时间: 2019年7月4日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
150
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •Inclusion Criteria:
  • •1) Subject’s parent or legal guardian must sign a written informed consent.
  • •2) Subject must sign a written informed assent.
  • •3) Subjects must be age (=6 to <18 years of age) at time of screening.
  • •4) Subjects must weigh =18 kg (39.6 lbs).
  • •5) Subjects must have TS based on Diagnostic and Statistical Manual for Mental Disorders – 5th Edition (DSM-5 diagnostic criteria) for TS.
  • •6) Subjects must exhibit both motor and vocal tics that cause impairment with normal routines.
  • •7) Subjects must have a minimum score of 20 on the YGTSS-TTS at Screening and at Baseline visits with tic symptoms causing impairment in the subject’s normal routines, including academic achievement, occupational functioning, social activities, and/or relationships.
  • •8) Subjects must be off all medications used to treat motor or vocal tics for at least 21 days prior to Screening.
  • •9) Adolescent females of childbearing potential who are sexually active 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. They must also agree to use contraception for 30 days after their last dose of study drug.
  • •10) 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.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 150
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •Exclusion Criteria:
  • •1) Subjects with any primary mood disorder (DSM-5 criteria) at Screening.
  • •2) Subjects who have unstable medical illness or clinically significant abnormalities on laboratory tests, or ECG at Screening.
  • •3) Subjects with a significant risk of committing suicide based on history, routine psychiatric status examination, investigator’s judgment, or who had an answer of ‘‘yes’’ on any question other than 1–3 (currently or within the past 30 days) on the baseline/screening version of the Columbia Suicide Severity Rating Scale (C-SSRS).
  • •4) Subjects with a clinical presentation at Screening and/or history consistent with another neurologic condition that may have had accompanying abnormal movements (e.g., Huntington’s disease, Parkinson’s disease, Wilson’s disease, stroke, Restless Legs Syndrome).
  • •5) Female subjects who are currently pregnant or lactating or planning to become pregnant during the course of the study.
  • •6) Subjects who have moderate to severe renal insufficiency at Screening given the large increase in systemic exposure of ecopipam and its active metabolite SCH 40853 observed in adults with moderate to severe renal impairment.
  • •7) Subjects who have hepatic impairment at Screening
  • •8) Subjects with current or recent (past 3 months) history of DSM-5 substance use disorder (with the exception of nicotine).
  • •9) Subjects with positive urine drug screen (cocaine, amphetamine, methamphetamine, tetrahydrocannabinol (THC), benzodiazepines, barbiturates, phencyclidine (PCP), opiates at Screening.
  • •10) Subjects with a change from grater than 25% or grater than or equal to 25% difference in the absolute change in YGTSS-TTS score between the Screening visit and the Baseline visit
  • •11) Subjects with a lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder.
  • •12) Subjects with a major depressive episode in the past 2 years.
  • •13) Subjects with a history of attempted suicide.
  • •14) Subjects with a first-degree relative with a major depressive episode that resulted in any psychiatric hospitalization, or attempted suicide with the exception of a hospitalization for post-partum depression.
  • •15) Subjects with a history of seizures (excluding febrile seizures that occurred >2 years in the past).
  • •16) Subjects with a history of neuroleptic malignant syndrome.
  • •17) Subjects with a myocardial infarction within 6 months.
  • •18) Subjects who have had previous treatment with ecopipam.
  • •19) Subjects who have had previous treatment with:
  • •o investigational medication within 3 months prior to Screening
  • •o depot neuroleptics within 3 months prior to Screening
  • •o other medications with possible effects on TS symptoms (i.e., lithium, pyschostimulants, naltrexone, VMAT2 inhibitors such as tetrabenazine, deutotetrabenazine, and valbenazine, baclofen, guanfacine, baclofen, benzodiazepines and botulinum toxin injections) within 2 weeks prior to Screening.
  • •o oral neuroleptics within 4 weeks prior to Screening
  • •20) Subjects receiving anti-depressant, anti-anxiety and anti-ADHD medications unless the dosage has been stable for a minimum of 4 weeks prior to Screening and not prescribed to relieve the neurological signs of TS.
  • •21) Subjects who received psychostimulants for the treatment of Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD) and developed and/or had exacerbations of the tic disorder after the initiation of stimulant treatment.
  • •22) Subjects who have a need f

研究者

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