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临床试验/EUCTR2019-000281-37-FR
EUCTR2019-000281-37-FR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6月26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 according to the requirements of the site’s IRB/EC.
  • •3) Subjects must be =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 in the investigator’s judgment causing:
  • •a. Subjective discomfort (e.g., pain or injury)
  • •b. Sustained social problems (e.g., social isolation or bullying)
  • •c. Social and emotional problems
  • •d. Functional interference (e.g., impairment of academic achievements)
  • •8) Subjects may not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline.
  • •9) Adolescent females of childbearing potential who are sexually active must be using highly effective contraception (i.e., oral contraceptives, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized male partner) and agree to continue use of highly effective contraception for the duration of their participation in the study. They must also agree to use highly effective contraception for 30 days after their last dose of study drug.
  • •10) Sexually active male subjects must use a highly effective method of contraception during the study and agree to continue the use of highly effective contraception for at least 30 days after the last dose of study drug.
  • •11) The subject has received an adequate trial of non-pharmacological therapy without adequate response prior to study enrollment as documented by the Investigator.
  • •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 unstable 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 as determined by the Principal Investigator.
  • •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.
  • •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 for cocaine, amphetamine, methamphetamine, benzodiazepines, barbiturates, phencyclidine (PCP), or opiates at Screening, except those receiving stable, prescribed treatment for attention deficit/hyperactivity disorder (ADHD)
  • •10) Subjects with a > 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 other 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 history of seizures (excluding febrile seizures that occurred >2 years prior to Screening).
  • •15) Subjects with a history of neuroleptic malignant syndrome.
  • •16) Subjects with a myocardial infarction within 6 months.
  • •17) Subjects who have had previous treatment with ecopipam.
  • •18) Subjects who have had previous treatment with:
  • •o investigational medication within 1 month prior to Screening
  • •o depot neuroleptics within 3 months prior to Screening
  • •o oral neuroleptics within 4 weeks prior to Screening
  • •19) Subjects receiving anti-depressant, anti-anxiety or anti-ADHD medications unless the dosage has been stable for a minimum of 2 weeks prior to Screening and not prescribed to relieve the neurological symptoms related to TS.
  • •20) Subjects who have a need for medications which would have unfavorable interactions with ecopipam, e.g., dopamine antagonists or agonists [including bupropion], tetrabenazine, monoamine oxidase inhibitors, or St. John’s Wort.
  • •21) Initiation or changes in behavioral therapies for TS during the course of the study (i.e., Habit Reversal Training or Comprehensive Behavioral Intervention for Tics) as well as deep brain stimulation.
  • •22) Subjects who have initiated new behavioral therapies to treat TS fewer than 10 weeks prior to Baseline visit
  • •23) Subjects unable to swallow tablets
  • •24) Subjects with a known hypersensitivity to ecopipam or any of its excipients.

研究者

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