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

NCT01814189 | Completed Phase 3 DMC

• 1 other identifier: SB-045
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine With Aura; Migraine Without Aura

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Complete headache relief

  At 0.5 hour, 1 hour, and 4 hours after first dose

• Headache improvement.

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

• Using the second dose of study medications.

  At 2-48 hours after first dose.

• Using rescue medication between 2 and 48 hours postdose

  At 4-48 hours after second dose.

• Rate of headache recurrence

  At 2-48 hours after first dose.

Study Arms (2)

sumatriptan+promethazine (SPr)

ACTIVE COMPARATOR

The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg).

Drug: Sumatriptan+Promethazine (SPr)

Sumatriptan+placebo (SP)

PLACEBO COMPARATOR

The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine.

Drug: Sumatriptan+Promethazine (SPr)

Interventions

Sumatriptan+Promethazine (SPr) DRUG

Sumatriptan+placebo (SP); sumatriptan+promethazine (SPr)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Department of Neurology, Emam Hossein Hospital

Tehran, Tehran Province, 17666-33812, Iran

Location

MeSH Terms

Conditions

Migraine with Aura; Migraine without Aura

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant of Neurology

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 19, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

IR (1)