NCT00532532终止2 期
AV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple Sclerosis
Avigen27 个研究点 分布在 5 个国家目标入组 150 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
- 150
- 试验地点
- 27
- 主要终点
- To determine the long-term safety and tolerability of AV650 (tolperisone HCl) in subjects with spasticity associated with MS
研究概览
简要总结
A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity associated with multiple sclerosis. This study has three purposes:
- To determine whether AV650 is safe for patients with multiple sclerosis;
- To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with multiple sclerosis; and,
- To assess what the body does with AV650 once it is ingested (Germany and Czech Republic sites only).
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
- •Male or female subjects between 18 and 70 years of age (inclusive)
- •Signed and dated informed consent
- •Definite MS as per Poser or MacDonald Criteria (either relapsing remitting or secondary progressive course)
- •Expanded Disability Status Score (EDSS) from 3.0 to 6.5 (inclusive) at Screening
- •Stable MS for at least 30 days before screening
- •Female of child bearing potential and male subjects whose partner is of child bearing potential who are willing to ensure that they or their partner use effective double-barrier contraception during the study and for 90 days thereafter
- •If female, be neither pregnant nor nursing (Confirmation that the subject is not pregnant must be established by a negative serum hCG pregnancy test at baseline.)
- •Significant spasticity in at least two muscle groups defined as a score of 2 or more on the Ashworth scale for each muscle group
- •If a subject is on anti-spastic treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening
- •If a subject is on MS treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening
排除标准
- •Subjects who have participated in another research study within 90 days of Screening
- •Significant changes in anti-spasticity medications (dosage, frequency, or route of administration) within 30 days of Screening
- •Known hypersensitivity to tolperisone HCl, its components, or other lidocaine/lidocaine-like products
- •Use of tolperisone HCl within 30 days of screening
- •Significant changes in MS treatments (dosage, frequency, or route of administration) within 30 days of Screening
- •Spasticity due to neurological disorders other than MS
- •Any psychiatric disorder or cognitive impairment that precludes fully informed consent or safe participation in the study
- •Subjects who have suffered an acute relapse of MS or who continue to suffer from an acute relapse of MS within 90 days of Baseline
- •History of alcohol or substance abuse within one year of Screening
- •Concurrent clinically significant immunologic, pulmonary, renal, hepatic, or endocrine disease and/or other unstable or major disease other than MS
- •Clinically significant cardiovascular disorders, such as ischemic heart disease, arrhythmias, poorly controlled hypertension, or acute myocardial infarction
- •QT prolongation greater than 480 msec or greater than 450 msec if accompanied by a partial bundle branch block, or other ECG abnormality in the judgment of the Investigator
- •Diastolic blood pressure <50mmHg or >105mmHg; heart rate <50 beats per minute (bpm) or >110bpm, after 3 minutes in a sitting position; heart rate by ECG <50bpm or >110bpm
- •History of epilepsy (except childhood febrile seizures)
- •Current malignancy or history of malignancy that has not been in remission for more than five years, except basal cell skin carcinoma and cervical cancer (with treatment)
- •Female subject who is pregnant, nursing, or planning pregnancy during the course of the study
- •Scheduled elective surgery or other procedures requiring general anesthesia during the study
- •Subject who is terminally ill in the judgment of the Investigator
- •Subject who is inappropriate for placebo medication in the judgment of the Investigator
- •Systemic corticosteroid therapy within 28 days of randomization, with the exception of inhaled medications for asthma
- •Exacerbation of MS within 30 days of Baseline
- •Regular levo-dopa therapy within 7 days of randomization
- •Subjects taking antiarrhythmic medications
- •Donation of blood during the study
研究组 & 干预措施
1
Experimental
AV650 low dose
干预措施: tolperisone HCl (Drug)
2
Experimental
AV650 high dose
干预措施: tolperisone HCl (Drug)
3
Experimental
Placebo
干预措施: tolperisone HCl (Drug)
结局指标
主要结局
To determine the long-term safety and tolerability of AV650 (tolperisone HCl) in subjects with spasticity associated with MS
时间窗: 38 weeks
次要结局
- To determine preliminary efficacy of AV650 as compared to placebo in subjects with spasticity associated with MS; and to determine the pharmacokinetic (PK) profile of AV650 at two dose levels(38 weeks)
研究者
研究点 (27)
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