Preventive treatment of serotonin-migraine with 1,3,4,14b-tetrahydro-2,7-dimethyl-2H-dibenzo(b,f)pyrazino-(1,2--d)-(1,4)-oxazepine hydrogen maleate (Org GC 94). A double-blind study.
1,3,4,14b-Tetrahydro-2,7-dimethyl-2H-dibenzo(b,f)pyrazino-(1,2-d)-(1,4)-oxazepine hydrogen maleate (Org GC 94) is an oral "antamine" preparation with anti-serotoninergic and anti-histaminic effects. Its lack of unpleasant side-effects permits protracted use for the preventive treatment of serotonin-migraine. Its chemical structure--tetracyclic ring, C-beta, C-alpha, amine in a secondary position--allows block of the receptors for serotonin and histamine. Preventive treatment with 3 x 5 mg/day of Org GC 94 for a period of 3 months can almost completely eliminate migraine attacks. 21 out of 30 patients (70%) profited from such a treatment, showing a drop from 5--30 attacks to 0--1 attack per month and normalization of high urinary serotonin, 5-HIAA or histamine levels. However, 30 patients receiving 3 x 0.5 mg or placebo daily reacted only rarely. The typical side-effects of anti-serotonin drugs, especially sedation or dizziness and hyperorexia were hardly observed. Randomization of the serotonin-migraine cases and double-blind methodology were applied throughout the trial.
D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003989:Dibenzoxazepines / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006728:Hormones / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D012701:Serotonin / Q000502:physiology*
D003989:Dibenzoxazepines; D006728:Hormones; C012636:Org GC 94; D012701:Serotonin