A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (Study OS440-3006)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 442
- 主要终点
- Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets (80 mg/day) in MS patients with spasticity. Arbaclofen ER will be compared with placebo. The treatment groups will be randomized in a 1:1 ratio. There will be a 49-day dose escalation period, followed by a 84-day maintenance treatment period, followed by a 21-day taper period.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 to 65 years of age, inclusive
- •An established diagnosis per McDonald Criteria (Polman et al 2011) of MS (either RR or SP course) that manifests a documented history of spasticity for at least 6 months prior to screening
- •Spasticity due to MS as shown by a TNmAS-MAL score ≥ 2
- •Expanded Disability Status Scale (EDSS) score greater than or equal to (≥) 3.0 and less than or equal to (≤) 7.0
- •Absence of infections, peripheral vascular disease, painful contractures, advanced arthritis, or other conditions that hinder evaluation of joint movement
- •Use of a medically highly effective form of birth control (see Section 7.8) during the study and for 3 months thereafter for women of child-bearing potential (including female subjects and female partners of non-sterile male subjects)
- •Willing to sign the informed consent form (ICF)
排除标准
- •Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity
- •In the opinion of the investigator, the patient is unable to rate their level of spasticity or distinguish it from other MS symptoms
- •Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables
- •Pregnancy, lactation, or planned pregnancy during the course of the study and for 3 months after the final study visit
- •Current significant cognitive deficit, severe or untreated anxiety, severe or untreated depression
- •Current malignancy or history of malignancy that has not been in remission for more than 5 years, except effectively treated basal cell skin carcinoma
- •Any other significant disease, disorder, or significant laboratory finding which, in the opinion of the investigator, puts the subject at risk because of participation, influences the result of the study, or affects the subject's ability to participate
研究组 & 干预措施
Arbaclofen Extended-Release
Extended-release oral tablet, twice daily dosing (80 mg/day)
干预措施: Arbaclofen (Drug)
Placebo
Extended-release oral tablet, twice daily dosing
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL)
时间窗: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
The total numerical score of a limb accounts for the sum of the 3 main joint muscular group scores. The limb with the highest score is the most affected limb. Lower score is better. Scale is from 0 to 5.
Responder Analysis of Ashworth Scale Score (AS-MAL-R) for Maintenance Treatment Period
时间窗: Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)
Responder status (AS-MAL-R) consists of three response categorical outcomes based on the Ashworth Scale (AS). Where the possible outcomes are: Strong Responder, Responder, or Non-Responder
次要结局
- Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Total Limbs (TNmAS-TL)(Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133))
- Clinician's global impression of change (CGIC) for Maintenance Treatment Period(Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133))
- Numeric Rating Scale of Spasticity (NRS-S) for Maintenance Treatment Period(Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133))
- Expanded Disability Status Scale (EDSS) for Maintenance Treatment Period(Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133))