multiple sclerosis MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive
Conditions
Interventions
Product Name: n-acetylcysteine
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Acetylcysteine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Pharmaceu
Sponsors
ISTITUTO C. MONDINO
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective:  To evaluate the effect of combination therapy IFN beta 1a 44 mcg t.i.w. + 1200 mg N-Acetyl Cysteine vs IFN beta 1a 44 mcg t.i.w. + placebo on neurodegeneration as assessed by MRI spectroscopy during 24 months of treatment in subject with RR MS;Secondary Objective: To assess the effect of combination therapy on other MRI parameters of neurodegeneration To assess the effect of combination therapy in reducing lesions activity compared to monotherapy as assessed by MRI To assess the safety of combination therapy To assess the effect of combination therapy on clinical parameters;Primary end point(s): safety and efficacy | — |
Countries
Italy
Outcome results
None listed