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

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Migraine With Aura; Migraine Without Aura

Treatments: Drug: Sumatriptan+Promethazine (SPr)

Study type: Interventional

Funder types: Other

Identifiers

NCT01814189

SB-045

Details and patient eligibility

About

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

Enrollment: 350 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 2 patient groups, including a placebo group

sumatriptan+promethazine (SPr)

Active Comparator group

Description:

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

Treatment:

Drug: Sumatriptan+Promethazine (SPr)

Sumatriptan+placebo (SP)

Placebo Comparator group

Description:

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

Treatment:

Drug: Sumatriptan+Promethazine (SPr)