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

This study is not yet open for participant recruitment.
Verified October 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
ClinicalTrials.gov Identifier:
NCT03333109
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
The purpose of this study is to evaluate the efficacy and safety of AMG334 in countries beyond the United States (US) and European Union (EU).

Condition Intervention Phase
Migraine Biological: Erenumab Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study uses a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. A screening period of 2 weeks will be used to assess initial eligibility, followed by a 4-week baseline period. After randomization/Day 1, visits will occur at four week intervals until Week 12, which is the End of Treatment visit, Last Patient Last Treatment (LPLT). The final visit, Last Patient Last Visit (LPLV), a Safety Follow-Up visit, will occur 12 weeks later, at Week 24.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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)

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Change from baseline in monthly migraine days at the last month (Month 3) of the double-blind treatment period (DBTP) [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3 [ Time Frame: 3 months ]
  • Change from Baseline in acute migraine-specific medication treatment days at Month 3 [ Time Frame: 3 months ]
  • Change from Baseline in headache impact scores as measured by the HIT-6 at Month 3 [ Time Frame: 3 months ]

Estimated Enrollment: 880
Anticipated Study Start Date: February 5, 2018
Estimated Study Completion Date: February 7, 2020
Estimated Primary Completion Date: February 7, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG334 (erenumab) Dose 1
AMG334 Dose 1, administered by pre-filled syringe
Biological: Erenumab
AMG334 is a fully human monoclonal antibody targeting the CGRP receptor under development for migraine prophylaxis in adults.
Experimental: AMG334 (erenumab) Dose 2
AMG334 Dose 2, administered by pre-filled syringe
Biological: Erenumab
AMG334 is a fully human monoclonal antibody targeting the CGRP receptor under development for migraine prophylaxis in adults.
Placebo Comparator: Placebo
Placebo administered by pre-filled syringe
Other: Placebo
Placebo will match the active study drug and will be administered similarly.

  Eligibility

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.


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

Key inclusion criteria:

  1. Documented history of migraine in the 12 months prior to screening
  2. 4-14 days per month of migraine symptoms
  3. >=80% diary compliance during the Baseline period

Key exclusion criteria:

  1. >50 years old at migraine onset
  2. Pregnant or nursing
  3. History of cluster or hemiplegic headache
  4. Evidence of seizure or major psychiatric disorder
  5. Score of 19 or higher on the BDI
  6. Active chronic pain syndrome
  7. Cardiac or hepatic disease
  Contacts and Locations
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): NCT03333109


Contacts
Contact: Novartis Pharmaceuticals +41613241111 clinicaltrial.enquiries@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03333109     History of Changes
Other Study ID Numbers: CAMG334A2302
First Submitted: November 2, 2017
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017

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 ):
AMG 334, erenumab, migraine, episodic, headache, CGRP

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases