Effectiveness of topiramate in the treatment of migraine headaches in daily routine – results from the core phase of a 24-week open-label study

Objective: To explore the effectiveness of topiramate (TPM) in migraine prevention as prescribed by general practitioners under conditions of daily routine.

Methods: After a 4 week prospective baseline phase, patients with a diagnosis of migraine according to IHS criteria entered a 24 week open label non-interventional study (TOPMAT-MIG-4009) during which topiramate was initiated at 25mg/day and titrated flexibly based on clinical needs. Frequency of migraine attacks, intake of acute medication, pain intensity, adverse events, vital signs were documented.

Results: The ITT population consisted of 161 patients (90.7% female, mean age 45.7±11.1 years) with episodic migraine. 52.2% reported migraine with aura. TPM median dose was 45.7mg/day, median duration of follow up 24 weeks. Mean number of migraine days/4 weeks decreased from 6.9±3.8 days at baseline to 3.8±3.6 days at last core visit (LCV) (p<0.0001). Mean maximum pain intensity/4 weeks changed from 7.0±2.3 to 4.4±3.2at LCV (p<0.0001). Intake of triptans and other acute medication from baseline to LCV was reduced (p<0.001). 53% experienced an at least 50% reduction in migraine days/4 weeks. 51.9% of patients (N=185) had at least one treatment related adverse events (TRAE). TRAE ≥5% were paraesthesias (18.4%), nausea (18.4%), fatigue (10.3%), dysgeusia (8.1%), dizziness (7.6%), weight reduction (5.9%), headache (5.9%).

Conclusion: Results suggest that patients with episodic migraine might experience significant reduction in migraine frequency at low dose topiramate. This was associated with a decrease in intake in acute medication as well as pain intensity.