The Lancet Neurology has featured the results of a double-blind, placebo-controlled trial investigating the efficacy and safety of repeated suboccipital injections with cortivazol compared with placebo as add-on therapy in patients having frequent daily attacks.

The trial involved adults aged 18—65 years with more than two cluster headache attacks per day who were randomised to receive three suboccipital injections (48—72 hours apart) of cortivazol 3.75 mg or placebo, as add-on treatment to oral verapamil in patients with episodic cluster headache (n=28) and as add-on prophylaxis for those with chronic cluster headache (n=15). The primary outcome was reduction of the number of daily attacks to a mean of two or fewer in the 72 hour period 2—4 days after the third injection.

The following results were reported:

• 20 of 21 patients who received cortivazol had a mean of two or fewer daily attacks after injections compared with 12 of 22 controls (odds ratio 14.5, 95% CI 1.8—116.9; p=0.012).

• Patients who received cortivazol also had fewer attacks (mean 10.6, 95% CI 1.4—19.9) in the first 15 days of study than did controls (30.3, 21.4—39.3; mean difference 19.7, 6.8—32.6; p=0.004).

• Adverse events were reported by  18 (86%) of 21 patients who received cortivazol and 14 (64%) of 22 controls (p=0.162) - the most common adverse events were neck pain at the site of injection and headache other than cluster headache

The researchers concluded that suboccipital cortivazol injections can relieve cluster headaches rapidly in patients having frequent daily attacks, irrespective of type (chronic or episodic). However, safety and tolerability need to be confirmed in larger studies.

A related editorial has discussed this study – please see link below.