TerminatedPhase 4ACTRN12618000138280

The STELAR trial: Intravenous stemetil versus intravenous largactil for the treatment of acute migraine in adults

The STELAR trial: A prospective, randomised, double-blind trial assessing the effectiveness of intravenous chlorpromazine versus intravenous prochlorperazine on headache severity in the treatment of acute migraine in adults

Sponsor

Sarah Hodgson

Enrollment

70 participants

Start Date

Apr 23, 2018

Study Type

Interventional

Conditions

Migraine

Summary

Lay Summary: Several intravenous (IV) medications have been shown to be effective in alleviating the symptoms of migraine. At this time we do not know which of these medications is the most effective in patients presenting to hospital with persistent migraine, despite oral therapy. This study aims to compare the two common IV migraine medications used in Australasia: chlorpromazine and prochlorperazine. Our current migraine guideline in the Austin Hospital Emergency Department (ED) states that patients can be given either IV chlorpromazine or IV or intramuscular prochlorperazine for the treatment of migraine. Hence, both treatment regimens are considered as standard practice. Although there is a paucity of evidence available, we hypothesise that IV chlorpromazine is superior to IV prochlorperazine for the management of acute migraine in adults. Study design: This is a prospective, randomised, double-blind clinical trial comparing the efficacy of intravenous chlorpromazine versus intravenous prochlorperazine for the management of acute migraine in adults aged 18-65. This will be a single centre study, and will take place at the Austin Hospital. Method/intervention description: Patients age 18-65 years who present to the Austin ED with migraine, and who meet the criteria in the current Acute migraine guidelines for management of adults in the ED will be considered eligible for assessment to participate in this trial. Eligible patients will be randomised to receive either: Chlorpromazine 12.5 mg with 500 mL sodium chloride 0.9% via intravenous infusion over 30 minutes Or, Prochlorperazine 12.5 mg with 500 mL sodium chloride 0.9% via intravenous infusion over 30 minutes. Patients will be assessed at 0, 30, 60 and 120 minutes post infusion of study drug, Basic observations will be recorded, and headache severity score and nausea severity score using a 11-point numerical rating scale will be recorded. Patients will also be asked if photophobia and phonophobia are present. Side effects will be recorded, and at 120 minutes patients will be assessed for postural hypotension, and for akathisia using a modified Prince Henry akathisia rating scale. At 120 minutes the trial is complete, and if patients symptoms have improved they will be discharged home as per the standard discharge protocol. Primary objective: To compare the change in headache severity 60 minutes after infusion of either IV chlorpromazine or IV prochlorperazine. Secondary objectives: 1. To compare the change in headache severity 30 and 120 minutes after infusion of either study drug. 2. To compare the change in nausea severity, photophobia and phonophobia at 30, 60 and 120 minutes after infusion of either study drug. 3. To compare the side effects of both study drugs. 4. To compare the proportion of patients in each group that require rescue therapy (additional medication to manage their symptoms).

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria31

Age greater than or equal to 18 or less than or equal to 65 years of age.
Meet Austin Health's acute migraine guidelines for management of adults in the emergency department (ED).
AND:
Meet modified International Classification of Headache Disorders (3rd Edition) - diagnostic criteria for migraine without aura:
Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
Headache has at least two of the following four characteristics:
Unilateral location
Pulsating quality
Moderate or severe pain intensity
Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)
During headache at least one of the following:
Nausea and vomiting
Photophobia and phonophobia
Not better accounted for by another diagnosis.
These criteria have been modified. The International Classification of Headache Disorders diagnostic criteria requires the patient to have had at least 5 attacks meeting these criteria, we will include any patient in whom this is not the first presentation. We hypothesise that few patients will be able to recall the exact number of migraines they will previously have suffered. This modification has also been used in a previous study to diagnose migraine prior to enrolment.
OR:
Meet International Classification of Headache Disorders (3rd Edition) - diagnostic criteria for migraine with aura:
At least two attacks fulfilling criteria A and B
A - One or more of the following fully reversible aura symptoms:
Visual
Sensory
Speech and/or language
Motor
Brainstem
Retinal
B - At least two of the following four characteristics:
At least one aura symptom spreads gradually over = 5 minutes, and/or two or more symptoms occur in succession
Each individual aura symptom lasts 5-60 minutes
At least one aura symptom is unilateral
The aura is accompanied, or followed within 60 minutes, by headache.
Not better accounted for by another diagnosis.

Exclusion Criteria12

First headache of this nature.
Worst headache they have ever had
New onset headache after age 50 years, if not previously investigated.
Atypical or unusual character that does not fulfil criteria for migraine.
Confusion or loss of consciousness.
Seizure.
Fever, myalgia, suspicion of meningism or signs of meningism on exam.
Abnormal neurological exam.
Temporal artery tenderness.
Allergy to either study drug.
Pregnancy or breastfeeding.
Parkinson's Disease.

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Interventions

Arm 1 - Chlorpromazine arm: 12.5 mg chlorpromazine hydrochloride administered in 500 mL sodium chloride 0.9% - given over 30 minutes as an IV infusion. Single dose. This is a fixed dose for all

Arm 1 - Chlorpromazine arm: 12.5 mg chlorpromazine hydrochloride administered in 500 mL sodium chloride 0.9% - given over 30 minutes as an IV infusion. Single dose. This is a fixed dose for all patients enrolled in the study and randomised to the chlorpromazine arm.