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

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

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

Study Overview

• Status: Completed
• Conditions: Migraine Without Aura; Migraine With Aura
• Intervention / Treatment: Drug: Sumatriptan+Promethazine (SPr)

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: March 14, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (Estimate): March 19, 2013

Study Record Updates

• Last Update Posted (Estimate): July 30, 2013
• Last Update Submitted That Met QC Criteria: July 28, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Migraine without Aura; Migraine with Aura; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Hypnotics and Sedatives; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Vasoconstrictor Agents; Diphenhydramine; Promethazine; Sumatriptan
• Other Study ID Numbers: SB-045