Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment

Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment: a Randomized, Double Blind Clinical Trial

The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine

Inclusion Criteria:

• Patients who aged 18 to 65 years with a clinical history of migraine with or without aura (International Headache Society categories 1.1 or 1.2) for at least 1 year
• Subjects who have mean frequency of 2-8 migraine attacks per month.

Exclusion Criteria:

• Complex form of migraine, medication overuse headache, history of chronic tension-type headache, ophthalmoplegic, basilar and hemiplegic migraine
• Uncontrolled hypertension (diastolic blood pressure >95 mm Hg or systolic blood pressure >160 mm Hg)
• History or clinical evidence of cerebrovascular or cardiovascular disorder
• Renal impairment or dialysis dependence
• Serious illness (physical or psychiatric disorders)
• Drugs and alcohol abuse
• Pregnancy and breastfeeding
• Allergy or hypersensitivity to promethazine or triptans
• Concurrent use of ergotamine-containing drugs, monoamine oxidize inhibitors, antidepressant, lithium