80149
document
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 .
80150
Intervention_Pharmacological
1,3,4,14b-tetrahydro-2,7-dimethyl-2H-dibenzo ( b , f ) pyrazino- ( 1,2 -- d ) - ( 1,4 ) -oxazepine hydrogen maleate ( Org GC 94 ) .
80151
Intervention_Pharmacological
1,3,4,14b-Tetrahydro-2,7-dimethyl-2H-dibenzo ( b , f ) pyrazino- ( 1,2-d ) - ( 1,4 ) -oxazepine hydrogen maleate ( Org GC 94 )
80152
Intervention_Pharmacological
Org GC 94
80153
Intervention_Control
placebo
80154
Outcome_Physical
migraine
80155
Outcome_Other
attack per month
80156
Outcome_Physical
and normalization of high urinary serotonin
80157
Outcome_Physical
5-HIAA or histamine levels
80158
Outcome_Adverse-effects
sedation
80159
Outcome_Adverse-effects
dizziness
80160
Outcome_Adverse-effects
hyperorexia
80161
Participant_Condition
serotonin-migraine
80162
Participant_Sample-size
30
80163
Participant_Sample-size
30 patients