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Completed

NCT Number: NCT03333109

Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients

This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine

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Key information

Conditions

Episodic Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, CABA, Buenos Aires, Argentina

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About this study

This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. The subjects were randomized to receive either erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period. After randomization/Day 1, visits occurred at four week intervals until Week 12, which was the End of Treatment. The final visit, Last Patient Last Visit was a Safety Follow-Up visit, which occurred 12 weeks later, at Week 24.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key inclusion criteria:

  • Documented history of migraine in the 12 months prior to screening
  • 4-14 days per month of migraine symptoms
  • >=80% diary compliance during the Baseline period

Key exclusion criteria:

  • >50 years old at migraine onset
  • Pregnant or nursing
  • History of cluster or hemiplegic headache
  • Evidence of seizure or major psychiatric disorder
  • Score of 19 or higher on the BDI
  • Active chronic pain syndrome
  • Cardiac or hepatic disease

Treatment and study plan

Erenumab

Biological

70 mg/mL pre-filled syringe administered subcutaneously

Other names: AMG334

Placebo

Other

Matching placebo in pre-filled syringe administered subcutaneously

Primary outcomes

  1. Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP)

    Time frame: Baseline up to Month 3

    A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria:

    • ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity
    • ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia

Secondary outcomes

  1. Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3

    Time frame: Baseline and at Month 3

    Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3. A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria:

    • ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity
    • ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia

  2. Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3

    Time frame: Baseline up to Month 3

    Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications include two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline is the number of migraine-specific medication treatment days in the baseline period.

  3. Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3

    Time frame: Baseline up to Month 3

    The HIT-6 is a short-form self-administered questionnaire based on the internet-HIT question pool. The HIT-6 was developed as a global measure of adverse headache impact to assess headache severity in the previous month and change in a patient's clinical status over a short period of time. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social). Each of the 6 questions is responded to using 1 of 5 response categories: "never," "rarely," "sometimes," "very often," or "always." For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the response provided. These points were summed to produce a total HIT-6 score that ranges from 36 to 78. Scores were categorized into 4 grades, representing little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78) due to headache. Lower values represent better outcomes, therefore negative change denotes improveme

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 12-week Double-blind, Randomized, Multi-center Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients (EMPOwER)

Acronym: EMPOwER

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2017
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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