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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shahid Beheshti University of Medical Sciences
• Treatments: Diphenhydramine; Promethazine; Sumatriptan

Criteria

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