NCT00228397已完成2 期
A Multicenter, Randomized, Double-blind, Long-term Extension Study to Determine the Safety, Tolerability, and Preliminary Efficacy of CCI-779 in Subjects With Relapsing Multiple Sclerosis.
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 221 人开始时间: 2003年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 221
- 主要终点
- Long-term safety.
研究概览
简要总结
To evaluate the safety and tolerability of long-term therapy with 3 dose levels of oral CCI-779 administered to subjects with relapsing MS who completed study 3066A2-205-WW.
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
- Single
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with relapsing-remitting MS or secondary progressive MS with relapses.
- •Successful completion of study 3066A2-205-WW with no major protocol violations.
排除标准
- •Pregnancy or lactation.
- •Clinically important abnormalities on the physical examination, vital signs, or electrocardiogram (ECG) performed at the last visit of study 3066A2-205-WW (day 252).
- •Any adverse events or findings observed in study 3066A2-205-WW that in the opinion of the investigators would preclude the subject's entry into the extension study.
- •Please refer to section 16.2 'Discontinuation and Withdrawal of Subjects' regarding withdrawal of patients who have any clinical abnormalities in hematology or laboratory test results obtained at the last visit of the double-blind active phase of study 3066A2-205-WW.
结局指标
主要结局
Long-term safety.
Listing and summary tables of AE and TEAEs, vital signs, laboratory evaluations, and ECG data will be generated.
次要结局
- Preliminary efficacy of long-term treatment.
- Lesions observed on MRI scans, clinical measures such as the EDSS scale, the 9-Hole Peg Test, the Paced Auditory Serial Addition Test and the Timed Ambulation 25-Foot Test, occurrence of relapse, will be analyzed at end -point (12 or 16 months).
- Only descriptive statistics will be performed.
研究者
相似试验
已完成
1 期
Safety, Tolerability and Pharmacokinetics of KUC 7483 CL Tablets in Healthy Male VolunteersHealthyNCT02259933Boehringer Ingelheim35
已完成
3 期
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset SeizuresPartial-onset SeizuresEpilepsyNCT01832038UCB Pharma SA473
已完成
3 期
Study on Safety and Efficacy of an Oral Contraceptive in Long CyclesContraceptionNCT00266032Bayer1,166
已完成
1 期
Japanese Phase 1 Multiple Ascending Dose (MAD) StudyDepressionNCT01396252Bristol-Myers Squibb57
已完成
1 期
3-part Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Multiple Doses of CC-220 and Relative Bioavailability of a Formulated CC-220 CapsuleHealthy VolunteersNCT02034773Celgene Corporation64