A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 主要终点
- Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
详细描述
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for up to 2 weeks. The study will also allow for an evaluation of the efficacy of NBI-98854 50 mg once daily for up to 6 weeks and the safety and tolerability of NBI 98854 50 mg once daily for up to 12 weeks.
The double-blind placebo-controlled treatment period the study has three arms:
- NBI-98854 50 mg once daily for 6 weeks
- NBI-98854 100 mg once daily for 2 weeks followed by 50 mg once daily for the remaining 4 weeks
- placebo
At the end of the 6-week placebo-controlled double-blind treatment period, subjects will continue in the study for an additional 6-week open-label period where all subjects who have completed the double-blind treatment period will receive NBI-98854 50 mg once daily. Two and four weeks after the last dose of study drug, follow-up assessments will be performed.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3 months prior to screening.
- •Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. Subjects who are not using antipsychotic medication must have stable psychiatric status.
- •Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study.
- •Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.
- •Female subjects must not be pregnant.
- •Be in good general health and expected to complete the clinical study as designed.
- •Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).
- •Have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine.
- •Have a negative alcohol breath test at screening and study start.
排除标准
- •Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening.
- •Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start(nicotine and caffeine dependence are not exclusionary).
- •Have a known history of neuroleptic malignant syndrome.
- •Have a significant risk of suicidal or violent behavior.
- •Receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine.
- •Receiving medication for the treatment of tardive dyskinesia.
- •Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result.
- •Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
- •Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
- •Have had previous exposure with NBI-98854.
研究组 & 干预措施
NBI-98854 50 mg
NBI-98854 50 mg administered as two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for 6 weeks.
干预措施: NBI-98854 (Drug)
NBI-98854 100 mg and 50 mg
NBI-98854 100 mg administered as two (2) 50 mg capsules taken every morning between 7:00am - 10:00am for 2 weeks. After 2 weeks, NBI-98854 50 mg administered by two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for remaining 4 weeks.
干预措施: NBI-98854 (Drug)
Placebo
Capsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.
干预措施: Placebo (Drug)
结局指标
主要结局
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6
时间窗: Baseline and Week 6
The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. The primary efficacy endpoint was the change from baseline in the AIMS dyskinesia total score at Week 6 between the pooled NBI-98854 50+100 mg group and placebo group analyzed using the ANCOVA model (LOCF, ITT analysis set).
次要结局
- Clinical Global Impression - Global Improvement of TD (CGI-TD)(Week 6)
- Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2(Week 2)