A Multi-center, Open-label Extension Study of the Safety and Tolerability of Long-term Administration of Oral CCI-779 (Temsirolimus) in Subjects with Relapsing Multiple Sclerosis Who Completed Study 3066A2-210-WW - N/A

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development0 个研究点目标入组 180 人开始时间: 2005年4月18日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Subjects with relapsing MS or secondary progressive MS with relapses who completed a minimum of 48 weeks of double-blind treatment in study 3066A2-210-WW.
•2. Women of childbearing potential must agree to continue to use a medically acceptable form of contraception throughout the study and for 3 months after the last dose of test article is administered.
•3. Male subjects must be willing to not father children during the study and for 3 months after the last dose of test article is administered.
•4. Subjects must be able and willing to provide signed and dated written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Pregnancy or lactation.
•2. Clinically important abnormalities on the physical examination, vital signs, chest radiograph, or electrocardiogram (ECG) performed at the last visit of the double-blind active phase of study 3066A2-210-WW.
•3. Any adverse events or findings observed in study 3066A2-210-WW that, in the opinion of the investigator, would preclude the subject’s entry into the extension study and would require extra medical care to the extent that the study visit schedule is inadequate.
•4. Immunomodulatory therapy including interferons, glatiramer acetate (Copaxone), and immunosuppressive therapy including mitoxantrone within 1 week of first test article intake.

发起方

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development