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 interferoneβ.

CompletedPhase 3Relapsing MS2013-001055-12

What it found

Missed its main goal

The main measure did not show a significant benefit.

“The differences between cetirizine and placebo in the intensity of FLS were not statistically significant: total mean VAS scores at 4 hours from IFNβ injection were 3.57 and 3.42 for cetirizine and placebo, respectively (difference -0.15; 95% confidence interval: from -0.74 to 0.44; p = 0.6029).”
Read by software from the paper's abstract
GroupnValue
cetirizine3.57
placebo3.42

mean difference -0.15 (95% CI -0.74–0.44)

p = 0.6029

Read by software from the paper's abstract

What was tested

Treatment tested

  • Cetirizine

What it measured

Main measures

  • See objectives.

Other measures (1)

  • See objectives.

Who could take part

Relapsing MS

Show the full criteria

Inclusion criteria

Inclusion: • Individuals of both sexes. Exclusion: • Subjects (male or female) of childbearing potential who are not using contraceptives

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

To evaluate the effectiveness of the administration of cetirizine 10 mg on the improvement of the symptoms of FLS.

Papers

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History

    1. Started

      Jun 2013

    Assembled by software from public sources.