NCT00666887已完成3 期
A Phase III Double-blind, Randomized, Placebo-controlled Trial of Minocycline in Clinically Isolated Syndromes (CIS) and Early Single Relapse Multiple Sclerosis (MS)
Dr. Luanne Metz12 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 12
- 主要终点
- To demonstrate that 100 mg of oral minocycline twice daily reduces the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to placebo, over a 6 month follow-up period.
研究概览
简要总结
The aim of the trial is to demonstrate that 100 mg of oral minocycline twice daily reduces the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to placebo, over a 6 month follow-up period (primary outcome).
A key secondary outcome is to confirm that this early treatment benefit is maintained at two years.
详细描述
- Minocycline 100 mg bid orally compared to identical placebo
- Clinically Isolated Syndrome (CIS): Patients with a first clinical demyelinating event suggestive of multiple sclerosis (At baseline participants may meet 2010 McDonald diagnostic criteria for MS, but not 2005 criteria)
- Men and women, aged 18-60y, first event within the previous 180 days; brain magnetic resonance imaging (MRI) with at least two brain T2 lesions which are at least 3 mm in diameter, and at least one of which is ovoid or periventricular or infratentorial.
- Up to 24 months of study drug (Up to 12 months of study drug for patients recruited after December 31, 2012)
- Patients will be discontinued from the study when they convert to McDMS based on the 2005 McDonald definition.
- 12 Canadian MS Clinics
- A total of 154 patients will be randomized. Because 30% of screened patients with CIS who are clinically eligible are not expected to meet the MRI criteria for inclusion, up to 280 patients will be screened.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years.
- •First focal clinical episode suggestive of demyelinating disease within the previous 180 days (measured from onset of the first symptom to treatment start), based on the appearance of a neurological abnormality, present for at least 24 hours.
- •Objective clinical evidence must be present or documented. Patients will be included irrespective of whether the first clinical demyelinating episode was monosymptomatic (i.e. clinical evidence of a single lesion) or polysymptomatic (i.e. clinical evidence of more than one lesion).
- •At least two lesions on the T2-weighted brain MRI* scan at least one of which is ovoid or periventricular or infratentorial. MRI eligibility will be determined centrally by the UBC MS/MRI Research Group.*One lesion on spinal MRI may substitute for one brain lesion as per the 2005 McDonald Criteria.
- •Sexually active women of child-bearing potential must agree to use adequate contraception.
- •Written informed consent
排除标准
- •Any disease other than MS that could better explain the patient's signs and symptoms.
- •Any previous clinical event reasonably attributable to acute demyelination, regardless of whether medical attention was obtained.
- •Complete transverse myelitis or bilateral optic neuritis. A waiver can be obtained for bilateral optic neuritis but must be obtained prior to randomization. Waivers must be approved by 3 neurologists including a member of the Clinical Eligibility / Endpoint Committee, a member of the DSMC, and by an experienced MS neurophthalmologist.
研究组 & 干预措施
Minocycline
Active Comparator
Minocycline 100 mg oral for up to 24 months
干预措施: Minocycline (Drug)
Placebo
Placebo Comparator
Lactose Monohydrate NF (Spray-dried) 235 mg/cap Magnesium Stearate NF 1 mg/cap Croscarmellose Sodium NF 4 mg/cap Stearic Acid 10 mg/cap Placebo CAP Lt orange OP-Purple OP (APO 100)
干预措施: Placebo (Drug)
结局指标
主要结局
To demonstrate that 100 mg of oral minocycline twice daily reduces the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to placebo, over a 6 month follow-up period.
时间窗: 6 Months
次要结局
- To confirm that this early treatment benefit is maintained at two years.(2 years)
- cumulative combined unique lesions (new enhancing T1-weighted lesions plus new and enlarging T2 lesions, without lesion double counting)(6 months and 24 months)
- Change in T2 lesion volume(6 months and 24 months)
- Cumulative number of enhancing T1 lesions(6 months and 24 months)
研究者
Dr. Luanne Metz
Principal Investigator
University of Calgary
研究点 (12)
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