A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- Number of Patients With Adverse Events
研究概览
简要总结
This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102 in subjects with MS (ADS-AMT-301).
详细描述
This was a multicenter, open-label study of ADS-5102 (amantadine) extended-release capsules in subjects with MS and walking impairment who completed study drug treatment for 16 weeks and completed a Week 16 visit in Study ADS-AMT-MS301.
All enrolled subjects were to receive ADS-5102 at 137 mg for the first week, 205.5 mg for the second week, and 274 mg for the remainder of the 52-week open-label treatment period.
Subjects returned to the clinic for safety and efficacy assessments at Weeks 4, 24, and 52. In addition, a telephone visit for safety assessments was conducted at Week 2 and Week 38. Subjects who withdrew from the study prior to completion of the Week 52 visit had an early termination (ET) visit that included safety and efficacy assessments. Subjects who completed 52 weeks of open-label treatment had a final visit for post-treatment safety follow-up and efficacy assessment at Week 54.
All study visits and efficacy assessments were to be scheduled to occur at approximately the same time of day for each individual subject. Each subject's efficacy assessment was to be performed by the same clinical rater, if possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed a current IRB-approved informed consent form
- •Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment.
排除标准
- •Based on the judgment of the investigator or Medical Monitor, participation in the study would jeopardize the safety of the subject.
- •If female, is pregnant or lactating
- •If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize a highly effective hormonal method of contraception (an IUD, or vasectomized male partner is also acceptable), in combination with a barrier method, from baseline through at least 4 weeks after the completion of study treatment. If a sexually active male, does not agree to utilize condoms from screening through at least 4 weeks after the completion of study treatment.
- •Anticipated treatment with any amantadine formulation other than ADS-5102
- •Planned participation in another interventional clinical trial
研究组 & 干预措施
ADS-5102, 274 mg
274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks
干预措施: ADS-5102, 274 mg (Drug)
结局指标
主要结局
Number of Patients With Adverse Events
时间窗: Through study completion, an average of 1 year.
The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.
次要结局
- Timed up and go (Week 24 Value)(24 weeks)
- Timed 25-Foot Walk (Feet/Second) (Week 52 Value)(52 weeks)
- Timed up and go (Baseline Value)(Baseline)
- Timed 25-Foot Walk (Feet/Second) (Week 24 Value)(24 weeks)
- Timed up and go (Week 52 Value)(52 weeks)
- 2-Minute Walk Test (Baseline Value)(Baseline)
- 2-Minute Walk Test (Week 52 Value)(52 weeks)
- Timed 25-Foot Walk (Feet/Second) (Baseline Value)(Baseline)
- 2-Minute Walk Test (Week 24 Value)(24 weeks)