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

Shahid Beheshti University of Medical Sciences350 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

350

Conditions

Migraine With Aura Migraine Without Aura

Interventions

Sumatriptan+Promethazine (SPr)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (1)

Department of Neurology, Emam Hossein Hospital

Tehran, Tehran Province, Iran

Outcomes

Primary Outcomes

Complete headache relief

The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing.

Time frame: At 2 hours after first dose

Secondary Outcomes

Complete headache relief

The secondary endpoint variable was the proportions of patients reporting complete headache relief 0.5 hour, 1 hour, and 4 hours after dosing.

Time frame: At 0.5 hour, 1 hour, and 4 hours after first dose

Headache improvement.

The secondary endpoint variable was the proportion of patients experiencing headache improvement at 0.5 hour, 1 hour, 2 hours, 4 hours after dosing.

Time frame: At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose.

Using the second dose of study medications.

The secondary endpoint variable was the use of second dose when the severity of headache was still moderate or severe after the first dose within 2-48 hours

Time frame: At 2-48 hours after first dose.

Using rescue medication between 2 and 48 hours postdose

The secondary endpoint variable was the use of rescue medication (excluding triptans, and ergot-containing medication) within 4-48 hours after the second dose when headache severity was still at grade 2 ⁄ 3.

Time frame: At 4-48 hours after second dose.

Rate of headache recurrence

The secondary endpoint variable was a return to moderate or severe pain within 48 hours of first dose subsequent to primary improvement to mild or no pain at 2 hours.

Time frame: At 2-48 hours after first dose.

Data from ClinicalTrials.gov

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