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

• Conditions: multiple sclerosis; MedDRA version: 9.1Level: HLTClassification code 10052785Term: Multiple sclerosis acute and progressive

• Registration Number: EUCTR2008-000955-90-IT
• Lead Sponsor: ISTITUTO C. MONDINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified