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

• Register: LBCTR
• Last refreshed on: 29 April 2024
• Main ID: LBCTR2019060240
• Date of registration: 23/05/2022
• Prospective Registration: No
• Primary sponsor: Novartis Pharma Services Inc.
• Public title: Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
• Scientific 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)
• Date of first enrolment: 08/02/2018
• Target sample size: 49
• Recruitment status: Complete
• URL: https://lbctr.moph.gov.lb/Trials/Details/5036
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial;Masking: Blinded (masking used);Control: Placebo;Assignment: Parallel;Purpose: Treatment
• Phase: 3

Countries of recruitment

Argentina, India, Lebanon, Malaysia, Mexico, Philippines, Republic of Korea, Singapore, Taiwan, Thailand, Viet Nam

Contacts

• Name: Hind Khairallah
• Affiliation: Khalil Fattal et Fils s.a.l.

• Name: Taghrid Hajj
• Affiliation: Rafik Hariri University Hospital

Key inclusion & exclusion criteria

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

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

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Migraine
Migraine

Migraine

Intervention(s)

•Biological: Erenumab
AMG334 is a fully human monoclonal antibody targeting the CGRP receptor under development for migraine prophylaxis in adults.

•Other: Placebo
Placebo will match the active study drug and will be administered similarly.

ICF, Physical Exam, ECG, local Labs

Primary Outcome(s)

Name: Change from baseline in monthly migraine days at the last month ;Timepoints: 3 months;Measure: 3 months

Secondary Outcome(s)

Name: •Change from Baseline in acute migraine-specific medication treatment days ;Timepoints: 3 months;Measure: 3 months

Name: •Achievement of at least a 50% reduction from baseline in monthly migraine days ;Timepoints: 3 months;Measure: 3 months

Name: •Change from Baseline in headache impact scores as measured by the HIT-6;Timepoints: 3 months;Measure: 3 months

Secondary ID(s)

NCT03333109

Source(s) of Monetary Support

Novartis Pharma Services Inc.

Ethics review

Status: Approved
Approval date: 25/10/2017
Contact:

[e-mail]

Bellevue Medical Center

[phone] ext 7600

[e-mail]

Status: Approved
Approval date: 09/11/2017
Contact:

[e-mail]

Makassed General Hospital

01636941

[e-mail]

Status: Approved
Approval date: 29/11/2017
Contact:

[e-mail]

Rafic Hariri University Hospital

018300000 ext 2036

[e-mail]

Status: Approved
Approval date: 23/12/2017
Contact:

[e-mail]

Ain w Zein Medical Village

[phone] ext 2000

[e-mail]

Status: Approved
Approval date: 24/01/2018
Contact:

[e-mail]

Lebanese American University- University Medical Center Rizk Hospital

[phone] ext. 2340

[e-mail]

Status: Approved
Approval date: 14/06/2018
Contact:

[e-mail]

American University of Beirut Medical Center

[phone] ext:5445

[e-mail]

Status: Approved
Approval date: 21/06/2018
Contact:

[e-mail]

Saint George Hospital University Medical Center

[phone]

[e-mail]

Results

• Results available: Yes
• Date Completed: 31/05/2019