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Trial details
Trial details
Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
Current status:
Approved
|
Date registered:
23/05/2022
Trial version(s)
History: 28/05/2019
History: 28/05/2019
History: 28/05/2019
Current: 28/05/2019
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Main Information
Primary registry identifying number
LBCTR2019060240
Protocol number
AMG334A2302
MOH registration number
49904/2017
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
LCTR was recently initiated, original file was previously submitted by Paper
Date of registration in national regulatory agency
20/12/2017
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
Acronym
EMPOWER
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)
Acronym
Brief summary of the study: English
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).
Brief summary of the study: Arabic
دراسة متعددة المراكز، عشوائية التوزيع، مزدوجة التعمية من 12 أسبوعًا تقارن ما بين فعاليّة وسلامة جرعة شهريّة واحدة تحت الجلد من دواء AMG 334 مقابل الدواء الوهمي لدى مرضى بالغين مصابين بالصداع النصفي العرضي (EMPOwER )
Health conditions/problem studied: Specify
Migraine
Interventions: Specify
•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.
Key inclusion and 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
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
65
Key inclusion and exclusion criteria: 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
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Other
Trial scope: Specify scope
Efficacy and safety
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
Yes, Worldwide
IMP has market authorization: Specify the countries
USA, Europe (Austria, Croatia, Czec republic, Denmark, Estonia, Finland, Germany, Iceland, Italy, Latvia, Poland, Portugal, Norway, Sweden, Switzerland, UK)
Name of IMP
erenumab (AIMOVIG)
Type of IMP
Others
Type of IMP: Specify
Calcitonin gene-related peptide (CGRP)
Pharmaceutical class
Erenumab (Aimovig) is a human monoclonal immunoglobulin G2 (IgG2) that is directed against the canonical CGRP receptor, where it inhibits and blocks the action of CGRP.
Therapeutic indication
Preventive treatment of migraine in adults.
Therapeutic benefit
The primary efficacy endpoint was 50% reduction in MMD while change from baseline in MMD was a secondary endpoint, also showed positive outcomes. Considering the totality of data, erenumab 70 mg has shown robust and consistent clinically and statistically significant efficacy with no significant dose-dependent adverse events, while erenumab 140 mg has shown even greater treatment effects along with a favorable safety and tolerability profile that was similar to erenumab 70 mg.
Biospecimen retention
Samples with DNA**
Biospecimen description
A central laboratory will be used for analysis of all specimens collected. Quintiles Ltd. – Scotland; Q² Solutions; The Alba Campus; Rosebank; Livingston; West Lothian; EH54 7EG; United Kingdom; Telephone: 01506816043 Hematology: red blood cells (RBCs), nucleated RBCs, hemoglobin, hematocrit, MCV, MCH, MCHC, RDW, reticulocytes, platelets, white blood cells (WBCs), WBC differential. The differential will measure: bands/stabs, neutrophils, eosinophils, basophils, lymphocytes, monocytes, myeloblasts, promyelocytes, myelocytes, metamyelocytes, and atypical lymphocytes. Chemistry: sodium, potassium, chloride, bicarbonate, total protein, albumin, calcium, magnesium, phosphorus, glucose, BUN/urea, bilirubin (direct and total), alkaline phosphatase, ALT (SGPT), AST (SGOT), total cholesterol, HDL, LDL, triglycerides, CPK, and eGFR. Urinalysis: specific gravity, pH, blood, protein, glucose, bilirubin, WBC, RBC, epithelial cells, bacteria, casts, and crystals
Target sample size
49
Actual enrollment target size
49
Date of first enrollment: Type
Actual
Date of first enrollment: Date
08/02/2018
Date of study closure: Type
Actual
Date of study closure: Date
13/11/2020
Recruitment status
Complete
Date of completion
31/05/2019
IPD sharing statement plan
Yes
IPD sharing statement 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
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT03333109
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinicaltrials.gov
NCT03333109
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Taghrid
Hajj
Beirut
Lebanon
03/494008
taghridelhajj@gmail.com
Rafik Hariri University Hospital
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Achraf
Makki
Beirut
Lebanon
70/878886
am132@aub.edu.lb
American University Of Beirut Medical Center
Public
Ghassan
Mehanna
Beirut
Lebanon
71/454849
drgmouhanna@gmail.com
Bellevue Medical Center
Public
Shawkat
Beayni
Chouf
Lebanon
03/700357
sh_beayni@hotmail.com
Ainwazein Medical Village
Public
Salim
Atrouni
Beirut
Lebanon
03/215679
atrounidr@hotmail.com
Makassed General Hospital
Public
Naji
Riachi
Beirut
Lebanon
03/229324
naji.riachi@laumcrh.com
Lebanese American University Medical Center Rizk Hospital
Public
Aline
Mourad
Beirut
Lebanon
70/472332
aline_mourad@hotmail.com
Saint Georges Hospital University Medical Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Rafic Hariri University Hospital
Dr. Taghrid Hajj
Neurologist
Approved
American University of Beirut Medical Center
Dr. Achraf Makki
Neurologist
Approved
Bellevue Medical Center
Dr. Ghassan Mehanna
Neurologist
Approved
Ain Wazein Medical Village
Dr. Shawkat Beayni
Neurologist
Approved
Makassed General Hospital
Dr. Salim Atrouni
Neurologist
Approved
Lebanese American University Medical Center Rizk Hospital
Dr. Naji Riachi
Neurologist
Approved
Saint George Hospital University Medical Center
Dr Aline Mourad
Neurologist
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
14/06/2018
Fouad Ziyadeh
fz05@aub.edu.lb
+961 (0) 1 350 000 ext:5445
Saint George Hospital University Medical Center
21/06/2018
Michel Daher
mndaher@stgeorgehospital.org
+961 (0)1 441 733
Bellevue Medical Center
25/10/2017
Ghassan Maalouf
gmaalouf@bmc.com.lb
+961 (0) 1 682666 ext 7600
Ain w Zein Medical Village
23/12/2017
Khaled Abdel Baki
Khaled.abdelbaki@awmedicalvillage.org
+961 (0) 5 509 001 ext 2000
Makassed General Hospital
09/11/2017
Mariam Rajab
research.makassed@hotmail.com
01636941
Lebanese American University- University Medical Center Rizk Hospital
24/01/2018
Christine Chalhoub
christine.chalhoub@lau.edu.lb
+961 9 547254 ext. 2340
Rafic Hariri University Hospital
29/11/2017
Rawan Yamout
rawan.yamout@crurhuh.com
018300000 ext 2036
Countries of Recruitment
Name
Lebanon
Argentina
India
Republic of Korea
Malaysia
Mexico
Philippines
Singapore
Taiwan
Thailand
Viet Nam
Health Conditions or Problems Studied
Condition
Code
Keyword
Migraine
Migraine (G43)
Migraine
Interventions
Intervention
Description
Keyword
ICF, Physical Exam, ECG, local Labs
ICF, Physical Exam, ECG, local Labs
ICF, Physical Exam, ECG, local Labs
Primary Outcomes
Name
Time points
Measure
Change from baseline in monthly migraine days at the last month
3 months
3 months
Key Secondary Outcomes
Name
Time points
Measure
•Achievement of at least a 50% reduction from baseline in monthly migraine days
3 months
3 months
•Change from Baseline in acute migraine-specific medication treatment days
3 months
3 months
•Change from Baseline in headache impact scores as measured by the HIT-6
3 months
3 months
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Clinical Study Report Amendment 01
06/05/2022
Download as PDF
Save a PDF copy of the summary of the trial