A prokinetic agent DA-9701 formulated with Corydalis tuber and Pharbitidis semen improves nausea in migraine: A prospective observational study

Nausea is common in migraines and is one of the most prevalent neurological disorders. Although migraine prophylaxis is known to reduce nausea, the impact of nausea treatment on migraine headache frequency remains unclear. DA-9701, a prokinetic derived from Corydalis tuber and Pharbitidis semen, offers serotonin 5-HT1A/5-HT4 agonism and D2 antagonism, with a reduced risk of adverse effects associated with traditional D2 antagonists. This study assessed the efficacy and short-term tolerability of DA-9701 in treating nausea and migraine and evaluated its secondary effect on reducing the frequency of migraine headaches. A cohort of 110 migraineurs with nausea received DA-9701 for 1 month. Using a headache diary, the monthly frequency of headache and nausea was recorded during a 1-month baseline and a 1-month treatment period. Changes in the number of nausea days per month were measured as the primary outcome. Changes in headache days and days requiring acute rescue medication were assessed as secondary outcomes using the DIEPSS. Further analyses were performed according to the migraine subtypes EM and CM. Nausea days decreased by 53.7% (-4.65 days; 95% confidence interval (CI) -10.66 to -4.66 days; P <.001). Headache days were reduced by 52.2% (-8.18 days; 95% CI -15.35 to -11.19 days;P <.001), and rescue medication days by 44.8% (-3.46 days; 95% CI -6.75 to -1.00 days; P <.001). In the CM group, changes in headache days were more prominent than those in nausea days (-13.47 vs -7.12 days; P <.001). No EPS or other clinically relevant adverse events were observed. DA-9701 was well tolerated and reduced both nausea and headache in migraineurs. The CM data suggest a potential independent prophylactic effect of DA-9701 on migraine headache. Larger randomized controlled trials are warranted.