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Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients (DRAGON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03867201
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : May 25, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Migraine Biological: Erenumab Other: Placebo Phase 3

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Study Type : Interventional
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : February 9, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Erenumab
Administered by pre-filled syringe
Biological: Erenumab
Administered by pre-filled syringe

Placebo Comparator: Placebo
Administered by pre-filled syringe
Other: Placebo
Administered by pre-filled syringe




Primary Outcome Measures :
  1. Change from baseline in monthly migraine days during the last 4 weeks of the 12-week treatment period [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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: 12 weeks ]
  2. Achievement of at least a 50% reduction from baseline in monthly migraine days during the last 4 weeks of the 12-week treatment period [ Time Frame: 12 weeks ]
  3. Change from baseline in monthly acute headache medication days during the last 4 weeks of the 12-week treatment period [ Time Frame: 12 weeks ]
  4. Number of subjects with adverse events as a measure of safety [ Time Frame: through study completion, an average of 20 weeks ]
  5. Number of subjects with anti-AMG 334 antibodies (binding and if positive, neutralizing) [ Time Frame: Day1, Week 12, Week 20 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

key inclusion Criteria:

  1. History of at least 5 attacks of migraine
  2. ≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period
  3. >=80% diary compliance during the baseline period

Key exclusion Criteria:

  1. Older than 50 years of age at migraine onset
  2. History of cluster or hemiplegic headache
  3. Evidence of seizure or major psychiatric disorder
  4. Cardiac or active hepatic disease
  5. Pregnant or nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867201


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
Show Show 52 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03867201    
Other Study ID Numbers: CAMG334A2304
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: May 25, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
AMG334
erenumab
migraine
chronic
headache
Chinese
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Erenumab
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs