NCT00531466终止2 期
AV650-014: A Four Week, Prospective, Randomized, Double Blind, Placebo-Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV650 in Patients With Spasticity Due to Spinal Cord Injury
Avigen10 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- To assess the safety, tolerability and PK profile of AV650 in subjects with spasticity due to spinal cord injury.
研究概览
简要总结
A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity following a spinal cord injury. This study has three purposes:
- To determine whether AV650 is safe for patients with spinal cord injury;
- To assess what the body does with AV650 once it is ingested; and,
- To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with spinal cord injury.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who provide written informed consent.
- •Male or female subjects aged 18 to 70 years.
- •In the judgment of the Principal Investigator, able to comply with protocol requirements.
- •Subjects willing and able to withdraw from other anti-spasmodic/muscle relaxant drugs for at least two weeks before randomization (including but not limited to baclofen, benzodiazepines, clonazepam, clonidine, dantrolene, diazepam, gabapentin, and tizanidine).
- •Neurological level between C-4 and T-12 spinal cord levels.
- •SCI duration of 6 or more months.
- •Muscle tone sufficient to score at least two (2) on the Ashworth Scale for at least one of the following lower muscle groups: ankle plantar flexors (gastrocnemius), knee extensors (quadriceps), knee flexors (hamstrings) and/or hip adductors (adductors) and seven (7) for the most spastic limb.
- •ASIA Impairment Scale Exam score of B, C or D.
- •Female subjects of childbearing potential must be either surgically sterile or using an effective method of contraception.
- •Female subjects of childbearing potential must have a negative urine pregnancy test at baseline (Study Day 0).
排除标准
- •Subjects with a known hypersensitivity to lidocaine or non-steroidal analgesics.
- •Subjects with clinically significant cardiovascular, pulmonary, endocrine, hepatic, renal, neurological, metabolic, or psychiatric disease.
- •Any recent history of mental illness, drug addiction, recreational drug use, or alcoholism and/or any similar condition that the investigator feels should prohibit study participation.
- •Any significant illness during the four weeks preceding Study Day
- •History of cancer or inflammatory arthritis of large joints.
- •History of gastric or duodenal ulcer.
- •Concurrent symptomatic urinary tract infections with fever.
- •Severe physical injury, direct impact trauma, or neurological trauma within the last 6 months not including Spinal Cord Injury.
- •ASIA Impairment Scale score of A or E.
- •Uncontrolled hypertension or hypotension.
- •Percussive tenderness of vertebral body or spinous process.
- •Subjects with corrective surgery to or contracture of the measurable hip, knee, or ankle joints.
- •Subjects known to be Hepatitis B or HIV positive.
- •Female subjects who are pregnant or nursing.
- •Subjects who have received an investigational drug within 30 days before Screening visit.
- •Subjects with any documented episodes of seizures.
- •Subjects requiring use of clinically relevant 2C19 or 2D6 inhibitors, or concomitant use of lidocaine.
- •Use of rescue medication(s) within 48 hours of baseline procedures.
研究组 & 干预措施
1
Active Comparator
干预措施: tolperisone HCl (AV650) (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety, tolerability and PK profile of AV650 in subjects with spasticity due to spinal cord injury.
时间窗: 1 month
次要结局
- To determine preliminary efficacy in subjects with spasticity due to SCI(1 month)
研究者
研究点 (10)
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