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Completed

NCT Number: NCT03867201

Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients

The purpose of this study was to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.

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Key information

Conditions

Migraine Brain Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Central Nervous System Diseases Graft vs Host Disease Headache Headache Disorders Headache Disorders, Primary Immune System Diseases Lung Diseases Lung Diseases, Obstructive Migraine Disorders Nervous System Diseases Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Beijing, Beijing Municipality, China

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About this study

This study used a single-cohort, 2-treatment arms, randomized (1:1 (70 mg:placebo)), double-blind study design in adult subjects with chronic migraine. A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period to assess diary compliance and headache frequency.

Eligible patients were then randomized to either erenumab 70 mg or placebo for 12 weeks, followed by an open-label treatment period to last until end of PTA determined by the product launch in the country or the country's decision not to launch. A safety follow-up visit occurred 12 weeks after the last treatment for subjects who discontinue the double-blind treatment or who completed the double-blind treatment period without continuing in the open-label treatment period.

Who can participate

Healthy volunteers accepted: No

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

key inclusion Criteria:

  • History of at least 5 attacks of migraine
  • ≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period
  • >=80% diary compliance during the baseline period

Key exclusion Criteria:

  • Older than 50 years of age at migraine onset
  • History of cluster or hemiplegic headache
  • Evidence of seizure or major psychiatric disorder
  • Cardiac or active hepatic disease
  • Pregnant or nursing

Treatment and study plan

Erenumab

Biological

Administered by pre-filled syringe

Other names: AMG334

Placebo

Other

Administered by pre-filled syringe

Primary outcomes

  1. Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period

    Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12

    A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria:

    • ≥2 of the following pain features:
    • Unilateral
    • Throbbing
    • Moderate to severe
    • Exacerbated with exercise/physical activity
    • ≥1 of the following associated symptoms:
    • Nausea and/or vomiting
    • Photophobia and phonophobia

Secondary outcomes

  1. Change From Baseline in Migraine-related Disability and Productivity as Measured by the mMIDAS During the Last 4 Weeks of the 12-week Treatment Period

    Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12

    The modified MIDAS is a 5-item self-administered questionnaire that sums the number of productive days lost over the past month in two settings: the workplace and the home. The MIDAS also assesses disability in family, social, and leisure activities. The MIDAS score is the sum of missed days due to a headache from paid work, housework, and non-work (family, social, leisure) activities; and days at paid work or housework where productivity was reduced by at least half.

  2. Number of Participants With at Least 50% Reduction From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period

    Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12

    A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria:

    • ≥2 of the following pain features:
    • Unilateral
    • Throbbing
    • Moderate to severe
    • Exacerbated with exercise/physical activity
    • ≥1 of the following associated symptoms:
    • Nausea and/or vomiting
    • Photophobia and phonophobia

  3. Change From Baseline in Monthly Acute Headache Medication Days During the Last 4 Weeks of the 12-week Treatment Period

    Time frame: baseline (4 weeks period prior to start of study drug), week 9 to 12

    An acute headache medication day was defined as a day when medication was taken to treat acute headache.

  4. Number of Subjects With Adverse Events as a Measure of Safety

    Time frame: DBTP: 12 weeks for participants entering the OLTP. 20 weeks for participants NOT entering the OLTP. OLTP: From week 12 until up to approximately 4 years.

    Number of subjects with adverse events was assessed separately in the double-blind treatment period (DBTP) and the open-label treatment period (OLTP).

  5. Number of Subjects With Anti-AMG 334 Antibodies

    Time frame: baseline, 20 weeks

    anti-AMG 334 antibodies assessed for binding and neutralizing)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 12-week Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Once Monthly Subcutaneous Erenumab 70 mg in Adult Chronic Migraine Patients

Acronym: DRAGON

Important dates

Study start
2019
Primary completion
2021
Study completion
2024
First posted
Mar 7, 2019
Registry last updated
Oct 16, 2025

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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