EUCTR2016-000630-22-NL进行中（未招募）1 期
An Open-Label, Long-Term Safety Study Including a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 227
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
- •a. Patient is younger than 18 years of age on day 1.
- •b. Patient weighs at least 44 pounds (20 kg) on day 1.
- •c. Patient is able to swallow IMP whole.
- •d. Patient and caregiver/adult are willing to adhere to IMP regimen and comply with all
- •study procedures.
- •e. Patient is in good general health, as indicated by medical and psychiatric history as
- •well as physical and neurological examination.
- •f. In the investigator’s opinion, the patient and caregiver/adult have the ability to
- •understand the nature of the study and its procedures, and the patient is expected to
- •complete the study as designed.
- •g. Patient and caregiver/adult provide written informed consent/assent, depending on the
- •child’s age, as appropriate, according to local regulations.
- •h. Females who are postmenarchal or =12 years of age may be included only if they
- •have a negative beta-human chorionic gonadotropin (ß-HCG) test on day 1 or are
- •sterile. Definitions of sterile are given in Appendix L.
- •i. Females who are postmenarchal or =12 years of age whose male partners are
- •potentially fertile (ie, no vasectomy) must use highly effective birth control methods
- •for the duration of the study (ie, starting at screening) and for 30 days or 5 half-lives,
- •whichever is longer after last dose of IMP. Further details are included in
- •Appendix L.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 227
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •a. Patient is 18 years of age or older.
- •b. Patient has a neurologic disorder other than TS that could obscure
- •the evaluation of tics.
- •c. The patient's predominant movement disorder is stereotypy
- •(coordinated movements that repeat continually and identically)
- •associated with autism spectrum disorder.
- •d. Patient has a confirmed diagnosis of bipolar disorder, schizophrenia,
- •or another psychotic disorder.
- •e. Patient has clinically significant depression at screening or day 1.
- •f. Patient has a history of suicidal intent or related behaviors within 2
- •years of screening:
- •? previous intent to act on suicidal ideation with a specific plan,
- •irrespective of level of ambivalence, at the time of suicidal thought
- •? previous suicidal preparatory acts or behavior
- •g. Patient has a history of a previous actual, interrupted, or aborted
- •suicide attempt.
- •h. Patient has a first-degree relative who has completed suicide.
- •i. Patient has clinically significant obsessive-compulsive disorder (OCD)
- •on day 1 that, in the opinion of the investigator, is the primary cause of
- •impairment.
- •j. Patient has received comprehensive behavioral intervention for tics
- •for TS or cognitive behavioral therapy for OCD within 4 weeks of
- •k. Patient has received any of the following concomitant medications
- •for tics within the specified exclusionary windows of screening prior to
- •dosing for washout:
- •? within 3 months: depot neuroleptics, botulinum toxin, or
- •tetrabenazine
- •? within 4 weeks: cannabidiol oil or valbenazine
- •? within 21 days: reserpine
- •? within 14 days: neuroleptics (oral), typical and atypical
- •antipsychotics (see Appendix A, Table 7), metoclopramide, levodopa,
- •and dopamine agonists
- •Note: Use of stimulant medications, including amphetamine,
- •methylphenidate, and lisdexamfetamine, is allowed if primary use is for
- •the treatment of ADHD, dosing has been stable for at least 2 weeks
- •before screening.
- •Note: Use of atomoxetine is allowed if the primary use is for the
- •treatment of ADHD, dosing has been stable for at least 4 weeks before
- •Note: Use of benzodiazepines is allowed if the primary use is not for tics,
- •and dosing has been stable for at least 4 weeks before screening.
- •Note: Use of topiramate (up to 200 mg/day) is allowed if the dosing has
- •been stable for at least 4 weeks before screening.
- •Note: Use of guanfacine or clonidine is allowed regardless of indication
- •(ie, if prescribed for tics or Tourette syndrome) if the dosing has been
- •stable for at least 4 weeks before screening and no changes to dose or
- •frequency are anticipated during the course of the study.
- •l. Patient has an unstable or serious medical illness at screening or day 1.
- •m. Patient has a QT interval corrected for heart rate using Fridericia's
- •formula (QTcF) interval value >450 msec (males) or >460 msec
- •(females), or >480 msec (with right bundle branch block) on 12-lead
- 另有 9 项未显示
研究者
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