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Trial registered on ANZCTR


Registration number
ACTRN12618000138280
Ethics application status
Approved
Date submitted
23/01/2018
Date registered
30/01/2018
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The STELAR trial: Intravenous stemetil versus intravenous largactil for the treatment of acute migraine in adults
Scientific title
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
Secondary ID [1] 293826 0
None
Universal Trial Number (UTN)
Trial acronym
The STELAR trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 306255 0
Condition category
Condition code
Neurological 305352 305352 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 300086 0
Treatment: Drugs
Comparator / control treatment
Arm 2 - Prochlorperazine arm:

12.5mg prochlorperazine mesilate administered in 500mL of 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 prochlorperazine arm.
Control group
Active

Outcomes
Primary outcome [1] 304501 0
The change in headache severity on a numerical rating scale (NRS, scale 0-10) at 60 minutes after infusion of either IV chlorpromazine with IV fluid or IV prochlorperazine with IV fluid.
Timepoint [1] 304501 0
60 minutes post study drug infusion.
Secondary outcome [1] 342166 0
The change in headache severity on a numerical rating scale at 30 and 120 minutes after infusion of either IV chlorpromazine with IV fluid or IV prochlorperazine with IV fluid.
Timepoint [1] 342166 0
30 and 120 minutes post study drug infusion.
Secondary outcome [2] 342167 0
The change in nausea severity on an numerical rating scale (scale 0-10), at 30, 60, and 120 minutes after infusion of either study drug.
Timepoint [2] 342167 0
30, 60, 120 minutes post study drug infusion.
Secondary outcome [3] 342168 0
The presence of side effects (e.g., hypotension [systolic BP < 90mmHg, or a change from baseline of > 20mmHg] at 30, 60 and 120 minutes, postural hypotension (an orthostatic drop in systolic BP by > 20mmHg) at the end of the 120 minute period, akathisia (assessed using a modified Prince Henry Hospital Akathisia Rating Scale), and dystonic reactions as assessed by the treating physician.
Timepoint [3] 342168 0
30, 60 and 120 minutes post infusion of study drug.
Secondary outcome [4] 342169 0
Percentage of patients from each group requiring rescue therapy (additional medication to manage their symptoms).
Timepoint [4] 342169 0
60 and 120 minutes post infusion of study drug.
Secondary outcome [5] 342295 0
The presence of photophobia (yes/no) at 30, 60, and 120 minutes after infusion of either study drug.
Timepoint [5] 342295 0
30, 60 and 120 minutes
Secondary outcome [6] 342393 0
The presence of phonophobia (yes/no) at 30, 60, and 120 minutes after infusion of either study drug.
Timepoint [6] 342393 0
30, 60 and 120 minutes

Eligibility
Key inclusion criteria
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:

1. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
2. 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)
2. During headache at least one of the following:
- Nausea and vomiting
- Photophobia and phonophobia

3. 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:

1. 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.

2. Not better accounted for by another diagnosis.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. First headache of this nature.
2. Worst headache they have ever had
3. New onset headache after age 50 years, if not previously investigated.
4. Atypical or unusual character that does not fulfil criteria for migraine.
5. Confusion or loss of consciousness.
6. Seizure.
7. Fever, myalgia, suspicion of meningism or signs of meningism on exam.
8. Abnormal neurological exam.
9. Temporal artery tenderness.
10. Allergy to either study drug.
11. Pregnancy or breastfeeding.
12. Parkinson's Disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by sealed opaque numbered envelopes.

Pre-randomised by pharmacy department.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size is based upon the primary endpoint i.e. numerical rating pain score at 60 minutes post administration of the study drug.

A minimum sample size of 33 participants in each group is required to demonstrate a difference in pain score of 2 at 60 minutes (expected SD 2.5, alpha 0.05, power 90%). This number has been rounded up to 35 participants in each group (total 70) to account for the estimation of the SD and to afford additional power to the study.

Microsoft Excel 2007 will be used for data storage and interpretation. The unpaired t-test will be employed to analyse the primary endpoint (pain score at 60 minutes) and other continuous variables. The Chi square tests will be employed to compare proportions. IBM SPSS Statistics will be used for statistical analysis.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9836 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 18614 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 298440 0
Hospital
Name [1] 298440 0
Austin Health Emergency Department
Address [1] 298440 0
Emergency Department
Austin Health
Studley Road
Heidelberg
Victoria
3084
Country [1] 298440 0
Australia
Primary sponsor type
Individual
Name
Sarah Hodgson
Address
Emergency Department
Austin Health
Studley Road
Heidelberg
Victoria
3084
Country
Australia
Secondary sponsor category [1] 297584 0
Individual
Name [1] 297584 0
Shaun Greene
Address [1] 297584 0
Emergency Department
Austin Health
Studley Road
Heidelberg
Victoria
3084
Country [1] 297584 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299436 0
Austin Health Human Research and Ethics Committee
Ethics committee address [1] 299436 0
Austin Health Human Research and Ethics Committee
Austin Health
Studley Road
Heidelberg
Victoria
3084
Ethics committee country [1] 299436 0
Australia
Date submitted for ethics approval [1] 299436 0
31/01/2018
Approval date [1] 299436 0
19/04/2018
Ethics approval number [1] 299436 0

Summary
Brief 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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80394 0
Dr Shaun Greene
Address 80394 0
Emergency Department
Austin Health
Studley Road
Heidelberg
Victoria
3056
Country 80394 0
Australia
Phone 80394 0
+ 61 03 94968409
Fax 80394 0
Email 80394 0
shaun.greene@austin.org.au
Contact person for public queries
Name 80395 0
Dr Sarah Hodgson
Address 80395 0
Austin Health
Studley Road
Heidelberg
Victoria
3056
Country 80395 0
Australia
Phone 80395 0
+61 03 9496 5000
Fax 80395 0
Email 80395 0
sarah.hodgson@austin.org.au
Contact person for scientific queries
Name 80396 0
Dr Sarah Hodgson
Address 80396 0
Emergency Department
Austin Health
Studley Road
Heidelberg
Victoria
3056
Country 80396 0
Australia
Phone 80396 0
+61 0449992471
Fax 80396 0
Email 80396 0
sarah.hodgson@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No - individual participant data for this trial will not be available. The only data available will be that published or presented.
What supporting documents are/will be available?
Study protocol
Summary results
No Results