Secondary efficacy outcomes of top-pro study: A randomized double-blind controlled trial of topiramate versus propranolol for prevention of chronic migraine

ABSTRACT

Background and aims: We conducted TOP-PRO-study, a double-blind RCT, to know whether propranolol is as efficacious as topiramate for the prevention of CM. In this paper, we report the secondary efficacy outcomes. Primary efficacy outcome showing the non-inferiority of propranolol have been described in another paper. Methods: CM patients aged above 18 years and less than 65 years of age, not on any preventive treatment were randomly allocated to receive topiramate (100 mg/day) or propranolol (160 mg/day). Secondary outcomes were mean change per 28 days at the end of 24 weeks compared to baseline in headache days, acute migraine treatment (AMT) days, visual analog scale (VAS) scores, headache impact-6 (HIT-6) scores, migraine specific quality of life (MSQOL) score and achievement of more than 50% reduction in headache days. Results: COVID-19 pandemic and lockdown halted the recruitment before the trial reached the planned sample size of 244. Of the 175 randomized patients, 95 (topiramate 46 and propranolol 49) completed the trial. The two groups were matched in terms of age, sex and baseline headache parameters. At the end of 24 weeks, both groups showed similar mean improvements in headache days per 28 days (−7.7 vs −7.8;p = 0.928), >50% responder rate (32.6% vs 34.7%), AMT days (−6.7 vs −7.0;p = 0.835), VAS score (−1.7 vs −2.2;p = 0.355), HIT-6 score (−5.2 vs −7.3;p = 0.153), MSQOL score (−5.8 vs −9.3;p = 0.098). Conclusions: Propranolol was as efficacious as topiramate for the prevention of CM as assessed by multiple secondary outcome parameters. (Academic study Clinical Trials Registry-India CTRI/2019/05/018997).