Status:
COMPLETED
Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Conditions:
Migraine With Aura
Migraine Without Aura
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01814189
Start Date
January 1 2013
End Date
April 1 2013
Last Update
July 30 2013
Active Locations (1)
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1
Department of Neurology, Emam Hossein Hospital
Tehran, Tehran Province, Iran, 17666-33812