Study to evaluate the efficacy of cetirizine in the treatment of Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß.

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2013-001055-12-IT
• Date of registration: 03/06/2013
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Italia S.r.l.
• Public title: Study to evaluate the efficacy of cetirizine in the treatment of Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß.
• Scientific title: Flu-like syndrome Inhibition Giving anti-histaminic Therapy. Randomized cross-over, single-center, randomized, placebo-controlled, double-blind study to evaluate the efficacy of cetirizine on Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß. - FLU-LIGHT
• Date of first enrolment: 28/05/2015
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001055-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Italy

Contacts

• Name: Guido Sabatella
• Affiliation: Biogen Idec Italia S.r.l.

• Name: Guido Sabatella
• Affiliation: Biogen Idec Italia S.r.l.

Key inclusion & exclusion 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:
• 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Intervention(s)

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 HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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).

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 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.

Secondary Outcome(s)

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 .

Secondary ID(s)

BIIT0212

Source(s) of Monetary Support

Biogen Idec Italia S.r.l.