## Protocol Section
### Identification Module
**NCT ID:** NCT06428838

**Brief Title:** Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context

**Official Title:** Eptinezumab as an Adjunct to Standard of Care for MIGRANE in an Acute EmeRgency Context (Migraine ERase Study)

#### Organization Study ID Info
**ID:** Medvedev_001
#### Organization
**Class:** INDUSTRY
**Full Name:** HealthTech Connex Inc.
### Status Module
#### Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** H. Lundbeck A/S

**Class:** UNKNOWN

**Name:** Centre for Neurology Studies, Surrey Neuroplasticity Clinic Inc.

**Class:** UNKNOWN

**Name:** Royal Columbian Hospital

**Class:** UNKNOWN

**Name:** Surrey Memorial Hospital

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Dr George Medvedev

#### Responsible Party

**Investigator Affiliation:** HealthTech Connex Inc.

**Investigator Full Name:** Dr George Medvedev

**Investigator Title:** Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of the study is to investigate how a medication called eptinezumab (Vyepti) given to patients in the Emergency Department (ED) might help prevent migraines from happening again. The results of this study may help inform better ways to manage patients with migraines in the ED.

Eptinezumab is currently approved by Health Canada for the preventive treatment of migraine, but its short-term effectiveness in the ED context is unknown. Unlike other migraine treatments used in the ED, eptinezumab can rapidly interrupt the migraine process, potentially also preventing migraine from coming back in the short term.

Most patients with a diagnosis of migraine have no access to preventative therapies. This study will be able to provide access to preventative therapy at the earliest stages of a migraine attack. Administering this medication in the ED may stop the attack more effectively compared to current therapies.

This study wants to see if eptinezumab could help stop migraines from coming back after individuals have been treated in the ED. The study will also explore whether eptinezumab could reduce how often individuals with migraine might need to come back to the ED, what other medications they might need alongside eptinezumab, and how they feel overall.

### Conditions Module

**Conditions:**

- Migraine

- Chronic Migraine

**Keywords:**

- acute treatment

- emergency

- monoclonal antibody

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized (1:1), controlled trial with standard of care (SoC) as control arm.

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 102

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** SoC will be delivered at the discretion of the treating physician

**Intervention Names:**

- Other: Standard of Care

**Label:** Standard of Care

**Type:** OTHER

#### Arm Group 2

**Description:** In addition to standard of care, participants randomized to the Standard of Care + Eptinezumab arm will receive a single infusion of eptinezumab (100mg/mL).

**Intervention Names:**

- Biological: Eptinezumab

- Other: Standard of Care

**Label:** Standard of Care + Eptinezumab

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Standard of Care + Eptinezumab

**Description:** The study treatment consists of a single infusion of eptinezumab (100mg/mL).

**Name:** Eptinezumab

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Standard of Care

- Standard of Care + Eptinezumab

**Description:** SoC may include a combination of Toradol, Metoclopramide, and/or Benadryl. Ketamine and/or Midazolam may also be used, according to a stepwise approach, at the discretion of the treating physician. The timing and dose of all medication(s) administered in the ED will be recorded.

**Name:** Standard of Care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Number of migraine days at week 1, as reported in daily Headache Diary

**Measure:** Number of migraine days at week 1

**Time Frame:** Baseline to Week 1

#### Secondary Outcomes

**Description:** Readmission to the Emergency Department (ED) as assessed by patient chart

**Measure:** Readmission to the Emergency Department (ED)

**Time Frame:** Baseline to Month 3

**Description:** The Generalized Anxiety Disorder 7-item (GAD-7) will be assessed at baseline, month 1 and month 3. The GAD-7 is a short self-report questionnaire assessing the severity of anxiety disorder. For each item, the participant is asked how bothered they have been by the problem in the last 2 weeks. The total score ranges from 0-21, and a score greater than 15 indicates severe anxiety. The recall period for the GAD-7 is 2 weeks.

**Measure:** Generalized Anxiety Disorder 7-item (GAD-7)

**Time Frame:** Baseline to Month 3

**Description:** The Headache Impact Test (HIT-6) will involve an assessment at baseline and at months 1 and 3. The HIT-6 (v1.0) is a Likert-type, self-reported questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. HIT-6 scores range from 36 to 78. Higher scores indicate a greater impact of headaches on the respondent's life, i.e., 36 = no impact, 78 = maximum impact. The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The assessment was developed to measure a wide spectrum of factors contributing to headache burden, and it has demonstrated reliability and validity. The recall period for the HIT-6 is 4 weeks.

**Measure:** Headache Impact Test (HIT-6)

**Time Frame:** Baseline to Month 3

**Description:** The PHQ-9 is a short self-report questionnaire assessing signs and symptoms of depression. The questionnaire consists of nine items which ask about the frequency and severity of depressive symptoms based on DSM-IV criteria. For each item, the participant is asked to rate the severity of the symptom on a scale from 0 to 3. The total score ranges from 0-27 with a higher score indicating more severe depressive symptoms. The recall period for the PHQ-9 is 2 weeks.

**Measure:** Patient Health Questionnaire (PHQ-9)

**Time Frame:** Baseline to Month 3

**Description:** The PGI-C will involve an assessment at 24-72hrs, week 1, month 1 and month 3. PGI-C is a one-item measure rating of the overall patient perceived improvement on a seven-point scale. Patients rate their change since treatment initiation as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse.

**Measure:** Patient Global Impression of Change (PGI-C)

**Time Frame:** Baseline to Month 3

**Description:** Number of monthly headache days as assessed by the Migraine Disability Assessment (MIDAS)

**Measure:** Number of monthly headache days

**Time Frame:** Baseline to Month 3

**Description:** Recurrence of migraine as reported in daily Headache Diary

**Measure:** Migraine recurrence

**Time Frame:** Baseline to Month 3

**Description:** The WPAI is a six-item validated instrument that measures aspects of work productivity and activity impairment due to migraine over the past 7 days with higher values, in the form of percentages, indicating greater impairment due to the respondent's health. Only patients that are currently employed (full-time, part-time, or self-employed) are eligible to respond to the items assessing work-related activities. Item 6 in the WPAI will be administered to those not in employment, providing the possibility of calculating activity impairment for patients that are not employed. The six items are used to derive four subscales: Absenteeism (proportion of missed work hours out of the total; scale 0-100%), Presenteeism (level of work impairment; scale 0-10), Overall work impairment (combination of absenteeism and presenteeism; scale 0-100%), and Activity impairment (impairment in daily activities; scale 0-10).

**Measure:** Work Productivity and Activity Impairment (WPAI)

**Time Frame:** Baseline to Month 3

**Description:** Sleep quality will be assessed with the question, "On average, about how many hours of sleep do you get per night?" with responses including "7-9 hrs", "6-6.9 hrs", "5-5.9 hrs" or "less than 5 hrs". The recall period will be 1 week.

**Measure:** Sleep Quality

**Time Frame:** Baseline to Month 3

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Adults between the ages of 19-75 with a history of migraines, as established at the time of presentation to the ED or known from the patient's chart;
2. Presenting to the emergency department with a migraine that meets ICHD-3 migraine headache criteria;
3. Provided signed informed consent;
4. Sufficient literacy and cognitive capacity to understand and complete patient self-rated questionnaires in English.

Exclusion Criteria:

1. Secondary headaches caused by an injury or underlying illness, such as a concussion, bleeding in the brain, an infection or a brain tumor
2. Current or history of severe cardiovascular disease or renal dysfunction
3. A systemic condition in the stage of active treatment (vasculitis, etc.)
4. Pregnant or at risk of becoming pregnant (absent contraception)
5. Currently enrolled in another investigational drug trial
6. Dosed with eptinezumab within the past 3 months
7. Currently on anti-CGRP therapy with monoclonal antibodies
8. Currently involved in active litigation
9. Any other condition which, in the opinion of the Investigator, would exclude the participant due to reasons of safety or data integrity
10. Hypersensitivity to the active substance or to any of the excipients

**Maximum Age:** 75 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** juliajoyes@healthtechconnex.com

**Name:** Julia Joyes Clinical Research Coordinator

**Phone:** 778-735-1945

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New Westminster

**Contacts:**

***Contact 1:***

- **Email:** Vesna.Ivkov@fraserhealth.ca

- **Name:** Vesna Ivkov

- **Role:** CONTACT

***Contact 2:***

- **Name:** George Medvedev Neurologist, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Canada

**Facility:** Royal Columbian Hospital

**State:** British Columbia

**Zip:** V3L 3W7

**Location 2:**

**City:** Surrey

**Contacts:**

***Contact 1:***

- **Email:** vesna.ivkov@fraserhealth.ca

- **Name:** Vesna Ivkov

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dr George Medvedev Neurologist, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Canada

**Facility:** Surrey Memorial Hospital

**State:** British Columbia

**Zip:** V3V 1Z2

### IPD Sharing Statement Module

**Description:** If the results of the study are published in the public domain, only aggregate/group data will be published.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000051270

- Term: Headache Disorders, Primary

- ID: D000020773

- Term: Headache Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M11852

- Name: Migraine Disorders

- Relevance: HIGH

- As Found: Migraine

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M9351

- Name: Headache

- Relevance: LOW

- As Found: Unknown

- ID: M22529

- Name: Headache Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M26657

- Name: Headache Disorders, Primary

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008881

- Term: Migraine Disorders

- ID: D000004630

- Term: Emergencies

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: Analg

- Name: Analgesics

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: AAll

- Name: Anti-Allergic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: LOW

- As Found: Unknown

- ID: M11845

- Name: Midazolam

- Relevance: LOW

- As Found: Unknown

- ID: M10674

- Name: Ketamine

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M22645

- Name: Ketorolac

- Relevance: LOW

- As Found: Unknown

- ID: M22646

- Name: Ketorolac Tromethamine

- Relevance: LOW

- As Found: Unknown

- ID: M11760

- Name: Metoclopramide

- Relevance: LOW

- As Found: Unknown

- ID: M7338

- Name: Diphenhydramine

- Relevance: LOW

- As Found: Unknown

- ID: M14268

- Name: Promethazine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
