Patients with relapsing remitting multiple sclerosis (RRMS) treated with interferoneß, suffering from flu-like syndrome (FLS). MedDRA version: 16.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Cetirizina Mylan Generics
Product Name: Cetirizina Mylan Generics
Pharmaceutical Form: Tablet
INN or Proposed INN: Cetirizina
CAS Number: 83881-52-1
Other descriptive name: CETIRIZINE HYDR
Sponsors
Biogen Idec Italia S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of the administration of cetirizine 10 mg on the improvement of the symptoms of FLS. The primary objective of the study was the mean change in subjective seriousness of the FLS, evaluated according to the judgment of the patient on a visual analogue scale (VAS-FLS).;Secondary Objective: The average variation of the severity of FLS (as assessed by the score of the symptoms of FLS (FLS-S)) between the measurements before injection, after 4-6 hours after injection and after 12-15 hours after injection during the entire study period, the proportion of patients with an average decrease = 2 points of FLS-S and the incidence of FLS (defined as increase of 2 or more points of FLS-S compared to the value before injection) after 4-6 hours after injection and after 12-15 hours of injection during the entire study period.;Primary end point(s): See objectives.;Timepoint(s) of evaluation of this end point: The score of the VAS-FLS scale will be detected prior to injection, 4-6 hours after injection of interferon ß and after 12-15 hours after the injection of interferon ß during the period of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): See objectives.;Timepoint(s) of evaluation of this end point: The score of the symptoms of FLS (FLS-S) between the detections before injection, after 4-6 hours after the injection of interferon ß and after 12-15 hours after the injection of interferon ß during the entire study period . | — |
Countries
Italy
Contacts
Public ContactGuido Sabatella
Biogen Idec Italia S.r.l.
Outcome results
None listed