Study results

• 151 cluster attacks were treated: 52 attacks with 5 mg ZNS, 49 with 10 mg ZNS, and 50 attacks with placebo.
• Both the 5 mg and 10 mg dosages provided significant relief at 30 minutes: ZNS 5 mg in 50% of participants and ZNS 10 mg in 63.3% of participants compared to 30% of patients who received the placebo.
• For pain-free status, ZNS 10 mg was superior to placebo at 15 minutes -- 22.0% for ZNS vs. 6% for placebo.
• Side effects were mild and occurred in 16% of attacks treated with placebo, 25% of attacks treated with 5 mg ZNS, and 32.7% treated with 10 mg ZNS.
• No serious adverse events (side effects) were reported.

Study conclusions

“Zolmitriptan nasal spray, at doses of 5 and 10 mg, is effective and tolerable for the acute treatment of cluster headache.” ²

Specifically:

• ZNS 5 mg was significantly superior to placebo for CH relief at all time points between 20 and 45 minutes.
• ZNS 10 mg was superior to placebo for both pain-free and CH relief at all time points between 15 and 45 minutes.
• The differences between 5 mg and placebo at 60 minutes were not significant, and only the 10-mg dose retained significant superiority over placebo. This in part is expected because the median duration of CH attacks is shorter than 60 minutes.

Summary

The severity of cluster headaches has long been compounded by the lack of effective acute treatment options. This study indicates that Zomig Nasal Spray, especially the 10 mg dosage, is a viable option for the acute treatment of cluster headaches.

Resources:

¹ Press Release: “New Treatment Effective for Most Severe Kind of Headache.” American Academy of Neurology. August 27, 2007.

² Rapoport, A.M., MD; Mathew, N.T., MD; Silberstein, S.D., MD: Dodick, D., MD; Tepper, S.J, MD; Sheftell, F.D., MD; Bigal, M.E., MD, PhD. “Zolmitriptan nasal spray in the acute treatment of cluster headache.” Neurology® 2007;69:821–826.