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Clomethiazole (Astra Arcus AB).

H Mucke1

  • 1Sanochemia Pharmazeutika AG, Boltzmanngasse 11, A-1090 Wien, Austria. Mucke_ham@csi.com

Idrugs : the Investigational Drugs Journal
|September 15, 2005
PubMed
Summary
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Clomethiazole showed no overall benefit in acute stroke patients. However, it significantly improved functional independence in a subgroup with large strokes, suggesting potential neuroprotective effects.

Area of Science:

  • Neuroscience
  • Pharmacology
  • Clinical Neurology

Background:

  • Clomethiazole, an established sedative and antiepileptic, was investigated for acute stroke treatment.
  • Astra initiated development for stroke, with regulatory filings anticipated.
  • Ongoing clinical trials explored its efficacy in large stroke, intracerebral hemorrhage, and safety with TPA.

Purpose of the Study:

  • To evaluate the efficacy of clomethiazole in reducing nerve damage in acute cerebrovascular ischemia.
  • To determine if clomethiazole offers significant treatment benefits in a broad stroke patient population.
  • To identify specific stroke subgroups that may benefit from clomethiazole treatment.

Main Methods:

  • A large-scale, multicenter, international Phase III trial (CLASS) involving 1360 acute ischemic stroke patients.

Related Experiment Videos

  • Subgroup analysis focused on patients with large stroke (n=545).
  • Preclinical studies in a marmoset model of permanent middle cerebral artery occlusion (MCAO).

    • Main Results:

    • The overall trial (CLASS) did not demonstrate a significant treatment effect for clomethiazole across all patients.
    • A significant benefit was observed in the subgroup of patients presenting with large stroke.
    • In the large stroke subgroup, 41% of clomethiazole-treated patients achieved functional independence at 90 days versus 30% on placebo.
    • Clomethiazole demonstrated reduced functional disability and brain damage in the marmoset MCAO model.

    Conclusions:

    • Clomethiazole did not show overall efficacy in acute stroke but demonstrated significant benefits in patients with large strokes.
    • The drug's action via the GABAergic pathway may contribute to its neuroprotective properties.
    • Further investigation into clomethiazole for specific stroke types, particularly large strokes, is warranted.