EUCTR2018-002270-48-HU进行中（未招募）1 期
A Randomized, Placebo-controlled Trial to Evaluate the Long-term (ie, Maintenance) Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects with Tourette’sDisorder - N/A
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 228
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
- •1) The subject is a male or female child or adolescent, 6 to 17 years of age (inclusive) at the time of signing the informed consent/assent.
- •2) The subject meets current DSM-5 diagnostic criteria for TD, documented at screening and made by an adequately trained clinician, as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version.
- •3) The subject has a TTS = 20 on the YGTSS at screening and baseline (Day 1).
- •4) The subject, a caregiver, and the investigator must all agree that the presenting tic symptoms cause impairment in the subject’s normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships.
- •5) Females of childbearing potential (all female subjects = 12 years of age and all female subjects < 12 years of age if menstruation has started) must have a negative pregnancy test and must not be pregnant or lactating.
- •6) Written informed consent must be obtained from the subject or a legally acceptable representative (eg, guardian or caregiver), in accordance with requirements of the trial site's institutional review board (IRB)/independent ethics committee (IEC) and local regulatory requirements, prior to the initiation of any protocol required procedures. In addition, the subject, as required by the trial center's IRB/IEC, must provide informed assent at screening and as such must be able to understand that he or she can withdraw from the trial at any time.
- •7)Ability, in the opinion of the principal investigator, of the subject and the subject’s legally acceptable representative (eg, guardian) or caregiver(s) to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medications, to read and understand the written word in order to complete subject-reported outcomes measures, and to be reliably rated on assessment scales.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)The subject presents with a clinical presentation and/or history that is consistent with another neurologic condition that may have accompanying abnormal movements.
- •These include, but are not limited to, the following:
- •Transient tic disorder
- •Huntington's disease
- •Parkinson's disease
- •Sydenham's chorea
- •Wilson's disease
- •Mental retardation
- •Pervasive developmental disorder
- •Tardive dyskinesia
- •Traumatic brain injury
- •Restless legs syndrome
- •2)The subject has a history of schizophrenia, bipolar disorder, or other psychotic disorder.
- •3)Subjects who receive psychostimulants for the treatment of attention-deficit hyperactivity disorder (ADHD) and who have developed and/or had exacerbations of the tic disorder after the initiation of stimulant treatment. (Note that subjects with ADHD who are treated with psychostimulants and have not developed new tics or a worsening of their current tics can be included if all other enrollment obligations are met).
- •4)The subject currently has a primary diagnosis that meets DSM-5 criteria for mood disorder.
- •5)The subject has severe obsessive-compulsive disease, as evidenced by a Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) score > 16.
- •6)The subject has taken aripiprazole within 1 month (30 days) of the screening visit.
- •7)The subject has a history of neuroleptic malignant syndrome.
- •8)Subject is a sexually active male or female of childbearing potential (FOCBP) (all female subjects = 12 years of age and all female subjects < 12 years of age if menstruation has started) who will not agree to practice 2 acceptable methods of birth control or who will not remain abstinent during the trial and for 30 or 90 days following the last dose of IMP for females and males, respectively. Abstinence will be permitted if it is confirmed and documented at every trial visit.
- •9)The subject represents a significant risk of committing suicide based on history (suicide attempt in past 1 year), routine psychiatric status examination, investigator’s judgment, or who has an answer of yes” on any question other than 1-3 (current or over the last 30 days) on the baseline/screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS).
- •10)The subject has a body weight < 16 kg.
- •11)Subjects who have taken neuroleptic or antiparkinson drugs within 14 days prior to baseline.
- •12)Subjects requiring cognitive-behavioral therapy (CBT) for TD during the trial period. CBT for other nonexclusionary disorders must remain consistent throughout the trial.
- •13)The subject has met DSM-5 criteria for any significant psychoactive substance use disorder within the past 3 months.
- •14)A positive drug screen for cocaine, alcohol, or other drugs of abuse (excluding caffeine, nicotine, or prescribed psychostimulants for ADHD). Investigators can choose to repeat a positive drug screen one time during screening period after concurrence from the medical monitor. A second positive test for any drug of abuse would be exclusionary.
- •15)Subject requiring medication not allowed per protocol.
- •16)Use of any cytochrome P450 (CYP)2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to baseline and for the duration of the trial.
- •17)Other nutritional or dietary supplements and nonprescription herbal preparations for TD (eg, cannabinoids, N-aceytlcysteine, omega-3 fatty acids, kava extracts, GABA supplements) within 7 days prior to baseline and for the duration of the tri
研究者
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