EUCTR2019-001807-19-ES进行中（未招募）1 期
An Open-Label, Long-Term Safety, Tolerability, and Efficacy Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (Open RECLAIM-DCP) - Open RECLAIM-DCP
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
- 185
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
入选标准
- •Patients who have completed Study TV50717-CNS-30080 have already met the criteria below:
- •1. Patient is of an eligible age from parent Study TV50717-CNS-30080.
- •2. Patient weighs at least 12 kg (26 lb) on day 1 of this study.
- •3. Patient is able to swallow TEV-50717 tablet whole.
- •4. Patient and caregiver/adult are willing to adhere to TEV-50717 regimen and comply with all study procedures.
- •5. Patient is in good general health, as indicated by medical and psychiatric history and physical and neurological examination.
- •6. 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.
- •7. Patient and caregiver/adult provide written informed consent/assent, depending on the child’s age, as appropriate, according to local regulations.
- •8. Females who are postmenarchal or =12 years of age may be included only if they have a negative ß-HCG test on day 1 or are sterile.
- •9. 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 day 1) and for 30 days after last dose of TEV-50717.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 185
- •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
- •Patients will not be randomized/enrolled in this study if they meet any of the following criteria:
- •1. Patient has a predominant movement disorder other than dyskinesia.
- •2. Patient’s predominant motor symptoms are dystonic.
- •3. Patient’s predominant motor symptoms are spastic.
- •4. Patient has another movement disorder that could impair the motor assessment in the MD-CRS part II.
- •5. Patient has clinically significant depression at day 1 of this study. Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose.
- •6. Patient has a history of suicidal intent or related behaviors: (a) previous intent to act on suicidal ideation with a specific plan, irrespective of level of ambivalence, at the time of suicidal thought; (b) previous suicidal preparatory acts or behaviour.
- •7. Patient has a history of a previous actual, interrupted, or aborted suicide attempt.
- •8. Patient has a first-degree relative who has completed suicide.
- •9. Patient who is currently receiving or who has received botulinum neurotoxin (BoNT) in an investigational clinical trial.
- •Note: Patients may be included in the study if they have at least 2 treatments of Food and Drug Administration-approved BoNT at a regular interval (eg, every 3 to 4 months), in reasonably stable dosages and locations (subject to investigator’s judgement) to treat lower limb spasticity or dystonia.
- •10. Patient has received any of the following concomitant medications for dystonia or chorea within the specified exclusionary windows of day 1 of this study: (a) within 3 months: depot neuroleptics; (b) within 30 days: tetrabenazine or valbenazine; (c) within 21 days: reserpine; (d) within 14 days: neuroleptics (oral), typical and atypical antipsychotics, metoclopramide, levodopa, dopamine agonists, and monoamine oxidase inhibitors.
- •11. Patient has received treatment with stem cells, deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for treatment of abnormal movements or CP, or the patient is not in a stable clinical condition.
- •12. Patient has recent surgical procedure or is anticipated to have a surgical procedure during the study that, in the opinion of the investigator, makes the patient unsuitable for the study.
- •13. Patient has a severe mental disability or an unstable or serious medical illness (eg, epilepsy) that, in the opinion of the investigator, could jeopardize or would compromise the patient’s ability to participate in this study.
- •14. Patient has a QT interval (QTc) corrected for heart rate using Fridericia’s formula (QTcF) value >450 msec on 12-lead ECG at day 1 of this study.
- •15. Patients with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure.
- •16. Patient has evidence of hepatic impairment, as indicated by the following: (a) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5× the upper limit of the normal range (ULN) at day 1 of this study; (b) alkaline phosphatase (ALP) or total bilirubin (Tbil) >2×ULN at day 1 of this study. Note: Patients with Gilbert’s syndrome are eligible to participate if approved by the medical monitor. Note: Patient
研究者
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