跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2019-000281-37-DE
EUCTR2019-000281-37-DE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12日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

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 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 in the investigator's
  • •judgment causing:
  • •a. Subjective discomfort (e.g. pain or injury)
  • •b. Sustained scoial problems (e.g., social isolation or bullying)
  • •c. Social and emotional problems
  • •d. Funtional interference (e.g., impariment of academic achievements)
  • •XML File Identifier: yjz7aJ3BAmMudkqQW55klU1qY3E=
  • •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 male
  • •contraception for at least 30 days after the last dose of study drug.
  • •11) For subjects enrolled outside of the United States and Canada, 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
  • •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
  • •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 YGTSSTTS
  • •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.
  • 另有 7 项未显示

研究者

相似试验

进行中（未招募）
1 期
Study to evaluate efficacy and safety of Ecopipam tablets in children and adolescent patients with Tourette's syndrome.Children and Adolescent Subjects with Tourette’s Syndrome grater than or equal to 6 and less than 18 years of age.
EUCTR2019-000281-37-FREmalex Biosciences, Inc.150
进行中（未招募）
1 期
Study to evaluate efficacy and safety of Ecopipam tablets in children and adolescent patients with Tourette's syndrome.Children and Adolescent Subjects with Tourette’s Syndrome grater than or equal to 6 and less than 18 years of age.
EUCTR2019-000281-37-PLEmalex Biosciences, Inc.150
进行中（未招募）
1 期
A Clinical Study of the Safety and Efficacy of Natalizumab in Acute Ischemic Stroke
EUCTR2015-004783-11-ESBiogen Idec Research Limited240
进行中（未招募）
1 期
A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study to Evaluate the Efficacy and Safety of 50 mg/day of DVS SR in Adult Outpatients With Major Depressive DisorderThe desvenlafaxine succinate sustained release formulation, DVS SR, is being used in development programs for the treatment of major depressive disorder (MDD).
EUCTR2008-005424-85-FRWyeth Research Division of Wyeth Pharmaceuticals Inc.850
进行中（未招募）
1 期
A Clinical Study of the Safety and Efficacy of Natalizumab in Acute Ischemic StrokeAcute Ischemic StrokeMedDRA version: 20.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852
EUCTR2015-004783-11-DEBiogen Idec Research Limited240