Study to evaluate the efficacy of cetirizine in the treatment of Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß.
- Conditions
- Patients with relapsing remitting multiple sclerosis (RRMS) treated with interferoneß, suffering from flu-like syndrome (FLS).MedDRA version: 16.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-001055-12-IT
- Lead Sponsor
- Biogen Idec Italia S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
• Individuals of both sexes.
• Persons aged between 18 and 55 years
• Individuals with Relapsing Remitting Multiple Sclerosis (RRMS).
• Treatment with IFNß 1a (im or sc) or 1b for at least 3 months.
• Negative pregnancy test performed no more than 30 days after the baseline visit (if applicable)
• FLS-S = 2 in spite of standard therapy (SOT) for the FLS.
• Individuals who do not have clinically significant conditions or situations, with the exception of MS, which in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
• Ability to provide written informed consent for participation in the study.
• Use of effective birth control methods or conditions of menopause for at least 6 months (if applicable).
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Subjects (male or female) of childbearing potential who are not using contraceptives
• Women who are pregnant or breast-feeding
• Intolerance or known contraindications to the use of cetirizine.
• Condition hereditary of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption
• Simultaneous participation in other studies
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method