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

Information source: Shahid Beheshti Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine With Aura; Migraine Without Aura

Intervention: Sumatriptan+Promethazine (SPr) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Shahid Beheshti Medical University


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Complete headache relief

Secondary outcome:

Complete headache relief

Headache improvement.

Using the second dose of study medications.

Using rescue medication between 2 and 48 hours postdose

Rate of headache recurrence

Occurrence of adverse events.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

Department of Neurology, Emam Hossein Hospital, Tehran 17666-33812, Iran, Islamic Republic of
Additional Information

Starting date: January 2013
Last updated: July 28, 2013

Page last updated: August 23, 2015

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