Randomized, single-blind, clinical and MRI study for evaluation of safety and efficacy of N-Acetyl Cysteine (NAC) associated with high-dose beta-Interferon in Relapsing-Remitting (RR) multiple sclerosis patients - renac

ISTITUTO C. MONDINO0 个研究点开始时间: 2008年3月12日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.Subjects must be between the ages of 18 and 50 years inclusive.
•2.Subjects may be male or female. Women of child- bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive or double-barrier method (condom or IUD with spermicide).
•3.Clinically Definite Multiple Sclerosis (CDMS) as defined by Mc Donald criteria
•4.Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5.0 inclusive.
•5.Subjects must have a relapsing-remitting disease course
•6.Subjects must have started therapy with IFN-beta-1a 44mcg s.c. t.i.w. within three months prior to the screening visit
•7.Subjects must be relapse-free within the 30 days prior to the screening visit.
•8.Subjects must not have taken corticosteroids (IV, IM and/or PO) within the 30 days, immunomodulators within the 60 days, immunosuppressors within 6 months prior to the screening visit
•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.Use of experimental or investigational drugs, including I.V. immunoglobulin, within 6 months prior to study entry.
•2.Chronic use of antioxidant substance(s), including NAC, (more than 30 consecutive days) within 60 days prior to the screening visit.
•3.Previous total body irradiation or total lymphoid irradiation (TLI)
•4.Pregnancy or breastfeeding.
•5.Significant medical or psychiatric condition that affects the subject?s ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse).
•6.A known history of uncontrolled asthma.
•7.A known history of sensitivity to acetylcysteine.
•8.Inability to successfully undergo MRI scanning.
•9.Primary or secondary epilepsy
•10.Hystory of brain trauma with sequelae

发起方

ISTITUTO C. MONDINO