Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context

Browse trials for

• Migraine Disorders 1,525
• Emergencies 1,687

Keywords

• acute treatment
• emergency
• monoclonal antibody

Study arms

• Other
  Standard of Care

  SoC will be delivered at the discretion of the treating physician

  Other: Standard of Care

• Experimental
  Standard of Care + Eptinezumab

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

  Biological: Eptinezumab · Other: Standard of Care

Interventions

• BiologicalEptinezumab

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

• OtherStandard of Care

  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.

Primary outcomes

1. Number of migraine days at week 1

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

   Time frame: Baseline to Week 1

Secondary outcomes

1. Readmission to the Emergency Department (ED)

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

   Time frame: Baseline to Month 3

2. Generalized Anxiety Disorder 7-item (GAD-7)

   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.

   Time frame: Baseline to Month 3

3. Headache Impact Test (HIT-6)

   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.

   Time frame: Baseline to Month 3

4. Patient Health Questionnaire (PHQ-9)

   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.

   Time frame: Baseline to Month 3

5. Patient Global Impression of Change (PGI-C)

   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.

   Time frame: Baseline to Month 3

6. Number of monthly headache days

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

   Time frame: Baseline to Month 3

7. Migraine recurrence

   Recurrence of migraine as reported in daily Headache Diary

   Time frame: Baseline to Month 3

8. Work Productivity and Activity Impairment (WPAI)

   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).

   Time frame: Baseline to Month 3

9. Sleep Quality

   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.

   Time frame: Baseline to Month 3

Individual participant data

Plan to share: No — If the results of the study are published in the public domain, only aggregate/group data will be published.