Background: Randomized clinical trials assessing the efficacy and tolerability of tonabersat compared with placebo as prophylaxis for migraine were systematically reviewed in this study. By analyzing all available data, we aimed to establish an overall estimate of any association in order to more accurately inform clinicians and care-givers about how to prevent migraines.
Objective: To evaluate the efficacy and tolerability of tonabersat when it is used for migraine prevention.
Study design: Systematic review of tonabersat for migraine prophylaxis.
Methods: Computerized database search of The Cochrane Pain, Palliative & Supportive Care Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), Pubmed, and EMBASE for randomized, double-blind, placebo-controlled trials on tonabersat for migraine until January, 2013. We also searched the ongoing trials. We did not impose any language restrictions.The quality assessment and clinical relevance criteria utilized were the Cochrane Pain, Palliative & Supportive Care review group criteria as utilized for randomized trials.
Outcome measures: The primary outcome measure was the change in mean number of migraine headache days. The secondary outcome measures were change in attacks, responder rates, the reduction of the consumption of rescue medication, and adverse events.
Results: For this systematic review, 133 studies were identified. Of these, 131 studies were excluded, and a total of 2 studies (after removal of duplicate publications) met inclusion criteria for methodological quality assessment with the randomized trial study. The evidence for tonabersat for migration prophylaxis failed to demonstrate a reduction when compared to placebo because of a lack of evidence. But the good tolerability supports further exploration of tonabersat in the prevention of migraine attacks.
Limitations: The limitation of this systematic review was a lack of available evidence.
Conclusion: There is fair evidence for migraine prophylaxis, but a lack of available evidence for tonabersat for migraine prophylaxis. Although tonabersat failed to demonstrate a significantly greater reduction of migraine headache days than placebo, it was well tolerated. Future work should further investigate the utility of tonabersat in the preventive management of migraine.