NCT03854019已完成3 期
Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Irritability as Assessed by The Irritability Scale.
研究概览
简要总结
The purpose of this study is to assess efficacy and safety of dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg) in patients with irritability due to Huntington's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •Verified HD mutation carriers;
- •Irritable as diagnosed by the Irritability Scale with a score > 14;
- •Stable concomitant medication (no change of medication during last 30 days prior to inclusion);
- •Written informed consent by prospective study participant before conduct of any trial-related procedure. Participant must be able to make an informed decision of whether or not to participate in the study.
排除标准
- •Hypersensitivity to dextromethorphan (e.g., rash, hives), quinine, mefloquine, quinidine, or dextromethorphan/quinidine with a history of thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome induced by these drugs;
- •Pregnant or nursing women;
- •Active suicidality based on the answer "yes" in questions 4 and 5 of the Columbia-Suicide Severity Rating Scale (baseline version);
- •Woman of childbearing potential, not using highly effective methods of contraception such as oral, topical or injected contraception, IUD, contraceptive vaginal ring, or double barrier method such as diaphragm and condom with spermicide) or not surgically sterile (via hysterectomy, ovarectomy or bilateral tubal ligation) or not at least one year post-menopausal;
- •Male not using an acceptable barrier method for contraception;
- •Presence of any medically not controllable disease (e.g. uncontrolled arterial hypertension or diabetes mellitus);
- •Clinically significant renal (calculated creatinine clearance < 30 ml/min) or hepatic dysfunction;
- •Patients with pre-existing hepatic disease;
- •Individuals with a history or complete heart block, QTc prolongation or tornadoes de pointes, or at high risk of complete AV block;
- •Family history of congenital QT prolongation;
- •History of unexplained syncope within the past year;
- •Use of drugs containing quinidine, quinine, or mefloquine;
- •Individuals currently taking strong CYP3A4 inhibitors or tetrabenazine;
- •Use of certain antidepressants--amitriptyline, clomipramine, desipramine, fluoxetine, paroxetine, sertraline, venlafaxine;
- •Use of certain heart rhythm medications--amiodarone, flecainide, procainamide, propafenone;
- •Use of certain medicines to treat psychiatric disorders--chlorpromazine, haloperidol, perphenazine, pimozide, quetiapine, risperidone, thioridazine.
- •Use of tamoxifen;
- •Presence or history of seizures or diagnosed epilepsy;
- •Severe cognitive disorders defined as a score < 18 on the MOCA;
- •Clinically relevant abnormal findings in the ECG, the vitals, in the physical examination or laboratory values at screening that could interfere with the objectives of the study or the safety of the subject as judged by the investigator;
- •Participation in another investigative drug trial within 2 months;
- •Subjects who are unlikely to be compliant and attend scheduled clinic visits as required as determined by the Investigator.
研究组 & 干预措施
Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg), then Placebo
Experimental
Dextromethorphan/quinidine (DM/Q) 20mg/10mg one capsule once daily for 1 week, followed by DM/Q 20mg /10 mg twice daily for subsequent 4 weeks, and finally DM/Q 20mg/10mg once daily for 7days.
干预措施: Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg) (Drug)
Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg), then Placebo
Experimental
Dextromethorphan/quinidine (DM/Q) 20mg/10mg one capsule once daily for 1 week, followed by DM/Q 20mg /10 mg twice daily for subsequent 4 weeks, and finally DM/Q 20mg/10mg once daily for 7days.
干预措施: Placebo (Drug)
Placebo, then Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg)
Placebo Comparator
Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days.
干预措施: Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg) (Drug)
Placebo, then Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg)
Placebo Comparator
Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days.
干预措施: Placebo (Drug)
结局指标
主要结局
Irritability as Assessed by The Irritability Scale.
时间窗: Baseline
The Irritability Scale total score ranges from 0 to 42, with higher scores indicating greater irritability.
Irritability as Assessed by The Irritability Scale
时间窗: 4 weeks
The Irritability Scale total score ranges from 0 to 42, with higher scores indicating greater irritability.
次要结局
- Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Severity Score.(4 weeks)
- Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Caregiver Distress.(4 weeks)
- Behavioral Symptoms, as Assessed by the Problem Behaviors Assessment - Short Version (PBA-s). - Irritability/Aggression Subscale(Baseline)
- Behavioral Symptoms, as Assessed by the Problem Behaviors Assessment - Short Version (PBA-s) - Irritability/Aggression Subscale(4 weeks)
- Motor Symptoms, as Assessed by the Total Motor Score (TMS) From the UHDRS.(4 weeks)
- Motor Symptoms, as Assessed by the Total Maximal Chorea (TMC).(4 weeks)
- Functional Independence, as Assessed by the UHDRS Total Functional Capacity Scale (TFC).(4 weeks)
- Number of Participants With Behavioral Suicidal Events, as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation.(Baseline)
- Behavioral Symptoms, as Assessed by the Hospital Anxiety and Depression Scale (HADS).(4 weeks)
- Number of Participants With Behavioral Suicidal Events, as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation(4 weeks)
- Number of Participants With Behavioral Suicidal Events, as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Behavior.(4 Weeks)
- Cognitive Symptoms, as Assessed by the The Montreal Cognitive Assessment (MoCA).(4 weeks)
- Patient Progress and Treatment Response Over Time, as Assessed by the Clinical Global Impressions Severity Scale (CGI-S).(4 weeks)
- Patient Progress and Treatment Response Over Time, as Assessed by the Clinical Global Impressions Improvement Scale (CGI-I).(4 weeks)
- Cognitive Symptoms, as Assessed by the Unified Huntington's Disease Rating Scale (UHDRS) - Cognitive Domain.(4 weeks)
研究者
Erin Furr Stimming
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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