A Pilot, Open Label, Clinical Trial Using Hydroxyzine in Multiple Sclerosis

I. Logothetis, I. A. Mylonas, S. Baloyannis, M. Pashalidou, A. Orologas, A. Zafeiropoulos, V. Kosta, T. C. Theoharides
  • International Journal of Immunopathology and Pharmacology, October 2005, SAGE Publications
  • DOI: 10.1177/039463200501800421

Clinical Trial Using Hydroxyzine in Multiple Sclerosis

What is it about?

Multiple sclerosis (MS) is an autoimmune disorder of myelin destruction. Blood-brain-barrier (BBB) disruption precedes pathological or clinical findings and could involve mediators from perivascular brain mast cells, such as histamine and vascular endothelial growth factor (VEGF). Mast cells could be activated by many triggers, including acute stress that has been correlated with MS exacerbations. We considered that the histamine-1 (HI) receptor antagonist hydroxyzine, which also partially inhibits brain mast cells and has anxiolytic properties, may reduce MS symptoms. This open label, pilot, clinical trial investigated the effect on MS of an oral solution of hydroxyzine (100 mg per day), together with caffeine (200 mg per day) to reduce sedation. Twenty patients (8 males; 12 females) with relapsing-remitting or relapsing-progressive MS completed the study (12 ± 1 months) and were evaluated using disability scales. Most patients on hydroxyzine (75%) remained stable or improved neurologically and all but one showed improved mood. Hydroxyzine could be used as an adjuvant in MS, but the small number of patients enrolled and the short duration of the study precludes any definitive conclusions. A double-blind, placebo-controlled study is warranted.

Why is it important?

In this study, we investigated the effect of the heterocyclic piperazine HI receptor antagonist hydroxyzine, which penetrates the BBB, on the disability ofMS patients. Hydroxyzine had previously been shown to inhibit neurogenic mast cell activation and EAE in rats (19). The present findings suggest that hydroxyzine might be useful in MS.


Professor Stavros J Baloyannis (Author)
Aristotle University of Thessaloniki

Our present data suggest that hydroxyzine may be useful in MS. Similar findings were obtained from a pilot double-blind, placebo-controlled, clinical trial using the same formulation of hydroxyzine and caffeine on relapsing-remitting MS A randomized, double-blind clinical trial with sufficient number of patients should be in order.

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The following have contributed to this page: Professor Stavros J Baloyannis