EUCTR2022-001685-35-SK招募中1 期
Clinical trial of (+)-a-dihydrotetrabenazine in patients with moderate to severe tardive dyskinesia with open-label Part I and randomized, double-blind, placebo-controlled Part II.
Adeptio Pharmaceuticals Limited0 个研究点目标入组 102 人开始时间: 2023年1月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Subject aged between 18 and 75 years, inclusive.
- •2.Subject with a clinical diagnosis of tardive dyskinesia.
- •3.Subject with symptoms of TD which are bothersome and/or cause functional impairment.
- •4.Subject with total motor AIMS score of =6, and with abnormal movements judged as moderate or severe by the Investigator (based on Item 8 of the AIMS).
- •5.Subject with body weight of not less than 45kg for females and 55kg for males.
- •6.Subject in a psychiatrically stable condition with no change in psychoactive medications (eg. neuroleptics, benzodiazepines, anticonvulsants, mood stabilizers etc.) within the last 30 days before Screening, and with no anticipated changes to the subject’s treatment regimen in the next 3 months.
- •7.Subject living in a stable environment as judged by the Investigator, with adequate supervision when necessary.
- •8.Subject having a caregiver who is in regular personal contact with the subject (no less than 5 days a week); if locally required.
- •9.Subject compliant with prescribed treatment regimen as judged by the Investigator.
- •10.Subject in good general health with expectation to attend all study visits and complete all study assessments as judged by the Investigator.
- •11.Subject able to read, comprehend and provide the written informed consent.
- •12.Subject able to complete subject-facing rating scales.
- •13.Female subject of childbearing potential who agrees to use a highly effective form of contraception (as defined by the Protocol) throughout the Study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 51
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 51
排除标准
- •1.Subject who received any of the following medications within 30 days of Screening or Baseline:
- •oTetrabenazine, deutetrabenazine, valbenazine, reserpine, a-methyl-p-tyrosine (AMPT),
- •oTrihexyphenidyl, orphenadrine, procyclidine, biperiden or other strong anticholinergics
- •oMetoclopramide, promethazine, and prochlorperazine
- •oMethylphenidate, amphetamine/dextroamphetamine, or other stimulants,
- •oMonoamine oxidase inhibitors (MAOIs)
- •oLevodopa or dopamine agonists
- •oBotulinum toxin (within 3 months of Screening)
- •Note: Existing medication for the subject’s TD symptoms must not be discontinued solely for the purpose of inclusion in this clinical trial.
- •2.Subject with a neurological condition that may interfere with the assessment of dyskinesia severity.
- •3.Subject with presence of parkinsonism, pheochromocytoma and prolactin dependent tumours, e.g. pituitary or breast cancer.
- •4.Subject with a serious psychiatric condition that is untreated or undertreated at Screening and/or Baseline.
- •5.Subject with active suicidal ideation at Screening or Baseline.
- •6.Subject with history of either previous intent to act on a suicidal ideation with a specific plan, or previous preparatory acts to commit suicide or suicidal behaviour, or a previous actual, interrupted or aborted suicide attempt.
- •7.Subject with an abnormal score on the depression subscale of the Hospital Anxiety and Depression Scale (HADS) at Screening or Baseline. Abnormal score is defined as score =11.
- •8.Subject with an unstable or serious medical condition at Screening or Baseline.
- •9.Subject with developmental disability or evidence of dementia confirmed by Mini-Mental State Exam (MMSE score =24).
- •10.Subject showing violent behaviour, or subject with a history thereof within 3 months of start of study participation.
- •11.Subject with clinically significant cardiac abnormality or QTcF >450 ms (males) or >470 ms (females) on 12-lead ECG at Screening.
- •12.Subject with any of the following abnormal values in laboratory test results at Screening:
- •oaspartate transaminase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limit of normal (ULN)
- •oalkaline phosphatase (ALP) or total bilirubin >2 times the ULN,
- •oserum creatinine >1.5 times the ULN
- •o any other results outside of laboratory reference ranges judged as clinically significant by the Investigator
- •opositive hepatitis B surface antigen (HbSAg, indicating ongoing hepatitis B infection), or
- •positive human immunodeficiency virus antibody (HIV-Ab), , or positive hepatitis C antibodies (HCV) test result.
- •13.Subject with a known allergy or hypersensitivity to any component of ADE513, or to a VMAT2 inhibitor e.g. tetrabenazine, deutetrabenazine, valbenazine.
- •14.Subject who has received any investigational drug product within 30 days (or 5 drug half-lives, if longer than 30 days) of Screening.
- •15.Subject acknowledging present alcohol or substance abuse at Screening, or subject with a history thereof within 12 months of Screening, or subject expected to be unable to refrain from substance abuse during the study.
- •16.Subject with a positive urine drug screen at Screening.
- •17.Pregnant or breastfeeding subject.
研究者
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