ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001616864

Ethics application status

Approved

Date submitted

21/10/2021

Date registered

26/11/2021

Date last updated

29/08/2022

Date data sharing statement initially provided

26/11/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

An evaluation of the efficacy of eptinezumab in the inpatient management of status migrainosus in comparison to intravenous lignocaine in patients who have failed other therapies

Scientific title

An evaluation of the efficacy of eptinezumab in the inpatient management of status migrainosus in comparison to intravenous lignocaine in patients who have failed other therapies

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

SMITE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Migraine

Condition category

Condition code

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A randomised, double-blinded parallel group controlled study to evaluate the safety and efficacy of eptinezumab against lignocaine in the inpatient treatment of status migrainosus.

Participants randomised to the Eptinezumab arm will receive 300mg via intravenous infusion over 30 minutes followed by placebo infusion (saline) for up to five days or until the migraine is aborted.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

The control treatment for this study is lignocaine as per standard treatment for status migrainosus at the study site.

Participants randomised to the lignocaine arm will receive a placebo (saline) intravenous infusion for 30 minutes followed by lignocaine 2mg/min via intravenous infusion for up to five days (as per site standard procedure) or until the migraine has been aborted.

The placebo infusion for both groups will be identical.

Control group

Active

Outcomes

Primary outcome [1]

Time from treatment initiation to discharge. Information collected by daily contact with participant during admission and confirmation from discharge confirmation in medical records.

Timepoint [1]

At time of acute hospital discharge

Primary outcome [2]

Visual Analogue Scale (VAS) of pain associated with migraine

Timepoint [2]

Day 1, Day 2, Day 3, Day 4 and Day 5 of admission

Primary outcome [3]

Use of rescue medications during admission collected via participant medical records

Timepoint [3]

At time of acute hospital discharge

Secondary outcome [1]

Healthcare Utilisation (primary health care provider visits and emergency department presentations) will be assessed as a composite secondary outcome. Information regarding healthcare utilisation will be collected from participants three months following their discharge from hospital.

Timepoint [1]

90 days following discharge from hospital

Secondary outcome [2]

Migraine Disability Assessment (MIDAS)

Timepoint [2]

Day 1 of participation (prior to initiation of treatment) and day 90 following discharge from hospital

Secondary outcome [3]

Safety of intervention based on laboratory (hematology and chemistry evaluation of blood samples) and vital signs assessments; blood pressure (digital blood pressure cuff), heart rate (pulse oximeter), temperature (thermometer), respiratory rate (visual assessment).

Timepoint [3]

Day 1, day 2, day 3, day 4 and day 5 of participation in the study and day 90 following participants' discharge from hospital

Secondary outcome [4]

Headache Impact Test (HIT- 6)

Timepoint [4]

Day 1 of participation (prior to initiation of treatment) and day 90 following discharge from hospital

Secondary outcome [5]

Work Productivity and Activity Impairment Questionnaire (WPAI)

Timepoint [5]

Day 1 of participation (prior to initiation of treatment) and day 90 following discharge from hospital

Secondary outcome [6]

Health related quality of life (EA-5D)

Timepoint [6]

Day 1 of participation (prior to initiation of treatment) and day 90 following discharge from hospital

Eligibility

Key inclusion criteria

- Aged 18 to 65 inclusive at time of presentation to ED
- At least a 1-year history of migraine with or without aura as per the ICHD-3 criteria
- Age of participant at the time of migraine onset <50 years old
- An acute migraine attack that has persisted for greater than or equal to 72 hours as per the ICHD-3 criteria for status migrainosus
- Ongoing symptoms despite, or contraindication to, triptan and chlorpromazine therapy
- In the opinion of the investigator and treating doctor, adequate investigation and consideration has been given for secondary causes of headache prior to enrolment.
- Written informed consent obtained from the participant prior to any study-related procedures

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia
- Current concomitant diagnosis of a secondary type of headache
- Chronic headache with continuous pain lasting more than three weeks
- Headache, which in the opinion of the investigator or delegate requires further investigation for secondary causes of headache
- Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal or neurologic disease
- Received an anti-CGRP product within 6 months
- History of known hepatic disease with potential for hepatic function impairment
- History of myocardial infarction, stroke, transient ischaemic attack, unstable angina or revascularisation procedure
- Cardiac arrythmia
- Newly diagnosed or uncontrolled hypertension
- Currently received treatment for another investigational drug or within 5 half-lives since ending treatment of another investigational drug.
- Clinically significant confounding pain disorder
- Uncontrolled or untreated major psychiatric condition
- BMI >39kg/m2
- Women who are pregnant, breastfeeding or planning to become pregnant during the study
- Previous ADR to lignocaine or other local anaesthetics
- History of malignancy (other than non-melanoma skin cancer, fully treated by excision)
- Previously received intravenous lignocaine for status migrainosus
- Need for contraindicated pro-arrhythmic or QT prolonging medication contraindicating lignocaine infusion

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

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

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

30/11/2021

Actual

27/04/2022

Date of last participant enrolment

Anticipated

15/11/2022

Actual

Date of last data collection

Anticipated

20/03/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Alfred Hospital

Address [1]

55 Commercial Road
Melbourne, VIC 3004

Country [1]

Australia

Primary sponsor type

Hospital

Name

Alfred Health

Address

55 Commercial Road
Melbourne, VIC 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

Level 5, 553 St Kilda Rd
Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/07/2021

Approval date [1]

17/09/2021

Ethics approval number [1]

77323 Local Project 443/21

Summary

Brief summary

This study is a randomised, double-blinded parallel group controlled study to evaluate the safety and efficacy of eptinezumab against lignocaine in the inpatient treatment of status migrainosus. Subjects who fulfil the International Classification of Headache Disorders, third edition criteria of migraine and status migrainosus and who have failed or are inappropriate to receive triptan and chlorpromazine therapy will be enrolled into this trial.

Upon randomisation, forty subjects will be allocated in a 1:1 ratio to receive either eptinezumab 300mg or placebo infusion, and admitted to hospital to receive intravenous lignocaine as standard medical therapy (if they received a placebo infusion on randomisation), or a placebo infusion for up to five days, or until their migraine is successfully treated.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jason Ray

Address

Alfred Hospital
55 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61 390762470

Fax

j.ray@alfred.org.au

Contact person for public queries

Name

Georgia Ramsay

Address

Alfred Hospital
55 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61 390762470

Fax

g.ramsay@alfred.org.au

Contact person for scientific queries

Name

Jason Ray

Address

Alfred Hospital
55 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61 390762470

Fax

j.ray@alfred.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All individual participant data, after de-identification.

When will data be available (start and end dates)?

Between 3 months and 5 years following publication of findings

Available to whom?

Researchers who request access backed by a methodologically sound proposal

Available for what types of analyses?

Those outlined in an approved proposal

How or where can data be obtained?

By arrangement with the corresponding author via j.ray@alfred.org.au

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Status migrainosus inpatient treatment with eptinezumab (SMITE): Study protocol for a randomised controlled trial.	2022	https://dx.doi.org/10.1136/bmjopen-2021-059647

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically