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

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

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

Conditions
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Migraine With Aura, Migraine Without Aura

Intervention / Treatment
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* Drug: Sumatriptan+Promethazine (SPr)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sumatriptan+promethazine (SPr)<br>The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg). | Drug: Sumatriptan+Promethazine (SPr)<br> <br> |
| Placebo Comparator: Sumatriptan+placebo (SP)<br>The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine. | Drug: Sumatriptan+Promethazine (SPr)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete headache relief | The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing. | At 2 hours after first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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. | 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. | At 2-48 hours after first dose. | 
| Occurrence of adverse events. | Presence or absence of adverse events occurred 4 hours after first dosing. | At 4 hours after first dose. |