NCT02064010撤回2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Behavior of Orally Administered SNC-102 in Subjects With Drug-Induced Tardive Dyskinesia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Efficacy as measured by changes from baseline in summary scores on the Abnormal Involuntary Movement Scale (AIMS)
研究概览
简要总结
This Phase 2 study was designed to evaluate the efficacy and safety of SNC-102 in subjects with drug-induced Tardive Dyskinesia (TD). To ensure an adequate evaluation of SNC-102, a randomized, double-blind, parallel-group, placebo-controlled trial was designed. Two dosing levels of SNC-102 are employed to evaluate the proposed dosing range. A target enrollment of 90 subjects with drug-induced TD will provide sufficient data to assess the efficacy and safety profiles of SNC-102 in the target population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 18-75 years of age.
- •Diagnosis, at least 3 months prior to the Screening Visit, of drug-induced TD
- •AIMS ≥3 (moderate or worse) for ≥1 body area, or AIMS = 2 (mild) for ≥2 body areas; and
- •>3 months exposure to antipsychotic drug or metoclopramide; and
- •Other causes of dyskinesia have been ruled out.
- •AIMS score is confirmed at the Screening Visit by the Principal Investigator and the Trial Reading Center, and at the Baseline Visit at least 1 week later by the Principal Investigator.
- •If using antipsychotic medication or metoclopramide, dose has been stable for at least 60 days prior to the Baseline Visit and is expected to remain stable through the course of the trial.
- •If using opioid medication, dose has been stable for at least 14 days prior to the Baseline Visit and is expected to remain stable through the course of the trial.
- •If using vitamin or dietary supplements, dose and type has been stable for at least 14 days prior to the Baseline Visit and is expected to remain stable through the course of the trial.
- •If using alcohol, willingness to limit intake to no more than 2 drinks/day through the course of participation in the trial, and to abstain for at least 12 hours prior to any assessment visit.
排除标准
- •Unstable psychiatric status, as indicated by any change in psychotropic medication (unless approved by the Sponsor), or by hospitalization, within 60 days prior to the Screening Visit.
- •Active drug or alcohol dependence or abuse.
- •Current use of cocaine, amphetamine, phencyclidine (PCP), or ketamine, documented either by history or by urinary drug screening at Screening and Baseline Visits. Drugs used to treat attention deficit-hyperactivity disorder are allowed if stable for at least 14 days prior to the Baseline Visit and are expected to remain stable through the course of the trial.
- •Risk of significant medication non-adherence, based on the judgment of the Principal Investigator.
- •Neurologic or psychiatric disorder that could interfere with the attribution of observed involuntary movements to TD, such as a primary movement disorder unrelated to medication.
- •History of neuroleptic malignant syndrome.
- •Significant risk, in the judgment of the Principal Investigator, of suicidal or violent behavior.
- •Receipt of new medication for the treatment of TD within 4 weeks prior to the Baseline Visit or anticipated while participating in the trial.
- •Initiation of oral contraceptive medication, or change in dose, within 30 days prior to the Screening Visit, or anticipated while participating in the trial.
- •Gastrointestinal disease such as short-bowel or other malabsorption syndrome which, in the judgment of the Principal Investigator, could interfere with absorption of orally-administered medication.
研究组 & 干预措施
SNC-102, low dose
Experimental
SNC-102 (Acamprosate calcium) tablet 4 week duration dosing
干预措施: SNC-102 (Drug)
SNC-102, high dose
Experimental
SNC-102 (Acamprosate calcium) tablet 4 week duration dosing
干预措施: SNC-102 (Drug)
Placebo
Placebo Comparator
Placebo tablet 4 week duration dosing
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy as measured by changes from baseline in summary scores on the Abnormal Involuntary Movement Scale (AIMS)
时间窗: 4 weeks
Determine the efficacy relative to placebo of SNC-102 in subjects with drug-induced tardive dyskinesia (TD), as assessed by changes from baseline to four weeks in summary scores on the Abnormal Involuntary Movement Scale (AIMS)
次要结局
- Compare the effectiveness of low dose and high dose of SNC-102(4 weeks)
- Determine the relationship between the PK profile and clinical effects of SNC-102(4 weeks)
- Assess the pharmacokinetic (PK) profile in TD subjects(4 weeks)
- Assess safety and tolerability of SNC-102 in the tardive dyskinesia population(4 weeks)
研究者
研究点 (1)
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