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Topiramate Efficacy for Treatment of Chronic Tension-Type Headache: Presented at IHS

By Claire Sowerbutt

KYOTO, JAPAN -- October 17 -- Patients who suffer from chronic tension-type headache (CTTH) might benefit from the prophylactic use of topiramate, according to data presented here during the 12^th Congress of the International Headache Society (IHS), held here October 9^th to 12^th.

The findings show a highly significant decline in headache frequency from 23.50 days per month at study baseline to 12.58 days during the final treatment phase at study week 24 (P < .0001).

Further, there were significant improvements in the frequency of severe headache, from 8.18 to 3.13 days per month (P < .0001), said lead investigator Christian Lampi, MD, professor of neurology and psychiatry, Pain and Headache Center, Linz General Hospital, Krankenhausstrasse, Austria.

While CTTH is a common presentation in tertiary headache centers, the condition remains clinically challenging to treat. Antidepressants, anticonvulsants, and muscle relaxants can be used, but their efficacy relative to placebo has been shown to be in the region of 30%. Topiramate has demonstrated significant efficacy for prevention of migraine, so Dr. Lampi and colleagues theorized that it might have efficacy in patients with CTTH.

Their open-label study evaluated the twice-daily administration of topiramate initiated at 25 mg/day and titrated up by 25 mg/week to 100 mg/day, for a total of 3 treatment periods over 24 weeks. The number of patients with CTTH analyzed for primary outcome was 49, and the number randomized was 51.

"What was very surprising was that within the first 3 months there was no statistically significant reduction in headache frequency," Dr. Lampi said. "In a post hoc analysis we found that in weeks 13 to 15 there were tremendous decreases in headache severity as well as frequency."

The results show a highly significant reduction (P < .0001) in average headache intensity from 6.13 (+/- 1.78) days per month to 2.07 (+/- 1.22). There was also a decrease in headache duration, from 8.0 (+/- 4.8) hours per day to 3.0 (+/- 4.1) at the third and final treatment period.

Dr. Lampi noted that participants reported improvements on visual analogue scales in quality-of-life, mood, and sleep domains. And use of concomitant analgesic medications declined significantly, he said.

Adverse events included mild to moderate somnolence and fatigue that could be related to topiramate use in 6 patients. Mild paresthesia was reported in 19 patients, however, it resolved within the first 4 to 6 weeks of treatment. Three participants withdrew from the study due to somnolence and difficulty with memory and concentration. One patient withdrew due to paresthesia.

Topiramate is associated with weight loss, and this was also reported in this study, with a mean loss of 2.14 kg from baseline to week 24 (71.64-69.50 kg, respectively; P < .0001).

"Topiramate is highly effective in preventing chronic tension type headache, but you have to use it for more than 3 months," Dr. Lampi concluded. "Why this is, we don't yet know. One possible explanation could be the length of time participants had suffered from headaches. The mean duration in this study was 2 years, so there is some kind of central sensitization. It is likely that it took 3 months to reduce the central sensitization."


[Presentation title: A Prospective, Controlled, Open-Label, Long-Term Study of the Efficacy and Tolerability of Topiramate in the Prophylaxis of Chronic Tension-Type Headache. Poster G026]

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