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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2013

Interventions

  • Drug: Sumatriptan+Promethazine (SPr)

Arms, Groups and Cohorts

  • Active Comparator: sumatriptan+promethazine (SPr)
    • The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg).
  • Placebo Comparator: Sumatriptan+placebo (SP)
    • The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Complete headache relief
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.
    • Time Frame: At 4 hours after first dose.
    • Presence or absence of adverse events occurred 4 hours after first dosing.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shahid Beheshti University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shadi Asadollahi, Research Assistant of Neurology – Shahid Beheshti University of Medical Sciences

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