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

Phase 3

Completed

• Conditions: Migraine With Aura; Migraine Without Aura
• Interventions: Drug: Sumatriptan+Promethazine (SPr)

• Registration Number: NCT01814189
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-19
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-28
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sumatriptan+promethazine (SPr)	Sumatriptan+Promethazine (SPr)	The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg).
Sumatriptan+placebo (SP)	Sumatriptan+Promethazine (SPr)	The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine.

Primary Outcome Measures

Name	Time	Method
Complete headache relief	At 2 hours after first dose	The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing.

Secondary Outcome Measures

Name	Time	Method
Complete headache relief	At 0.5 hour, 1 hour, and 4 hours after first dose	The secondary endpoint variable was the proportions of patients reporting complete headache relief 0.5 hour, 1 hour, and 4 hours after dosing.
Headache improvement.	At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose.	The secondary endpoint variable was the proportion of patients experiencing headache improvement at 0.5 hour, 1 hour, 2 hours, 4 hours after dosing.
Using the second dose of study medications.	At 2-48 hours after first dose.	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
Using rescue medication between 2 and 48 hours postdose	At 4-48 hours after second dose.	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.
Rate of headache recurrence	At 2-48 hours after first dose.	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.
Occurrence of adverse events.	At 4 hours after first dose.	Presence or absence of adverse events occurred 4 hours after first dosing.

Trial Locations

Locations (1)

Department of Neurology, Emam Hossein Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of