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Completed

NCT Number: NCT01814189

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

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

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Key information

Conditions

Migraine With Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine Without Aura Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Neurology, Emam Hossein Hospital

Tehran, Tehran Province, 17666-33812, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sumatriptan+Promethazine (SPr)

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. Occurrence of adverse events.

    Time frame: At 4 hours after first dose.

    Presence or absence of adverse events occurred 4 hours after first dosing.

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2013
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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