A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies

A 12-week Double-blind, Randomized, Multicenter Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients Who Have Failed Prophylactic Migraine Treatments

ClinicalTrials.gov Identifier: NCT03096834

Novartis Reference Number: CAMG334A2301

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have unsuccessfully failed other preventive migraine treatments.

Condition 
Episodic Migraine
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
247 participants
Start date 
Mar 20, 2017
Completion date 
Jan 19, 2021
Gender 
All
Age(s)
18 Years - 65 Years (Adult, Older Adult)

Interventions

Biological
AMG334 Pre-Filled Syringe (PFS)
subcutaneous injection of AMG 334
Biological
Placebo Pre-Filled Syringe (PFS)
Subcutaneous injection of placebo

Eligibility Criteria

Inclusion Criteria:

Documented history of migraine in the 12 months prior to screen
4-14 days per month of migraine symptoms
>=80% diary compliance during the Baseline period
Failure of previous migraine prophylactic treatments

Exclusion Criteria:

>50 years old at migraine onset
Pregnant or nursing
History of cluster or hemiplegic headache
Evidence of seizure or psychiatric disorder
Score of 19 or higher on BDI
Active chronic pain syndrome
Cardiac or hepatic disease

Study Locations

Australia
Novartis Investigative Site
-
Heidelberg, 3084
-
Australia
Austria
Novartis Investigative Site
-
Innsbruck, A 6020
-
Austria
Novartis Investigative Site
-
Vienna, 1090
-
Austria
Belgium
Novartis Investigative Site
-
Brussel, 1090
-
Belgium
Novartis Investigative Site
-
Gent, 9000
-
Belgium
Novartis Investigative Site
-
Hasselt, 3500
-
Belgium
Novartis Investigative Site
-
Leuven, 3000
-
Belgium
Czechia
Novartis Investigative Site
-
Prague, 120 00
CZE
Czechia
Novartis Investigative Site
-
Czech Republic, 18600
-
Czechia
Novartis Investigative Site
-
Praha 4, 140 59
-
Czechia
Denmark
Novartis Investigative Site
-
Glostrup, 2600
-
Denmark
Finland
Novartis Investigative Site
-
Helsinki, 00180
-
Finland
Novartis Investigative Site
-
Helsinki, 00930
-
Finland
Novartis Investigative Site
-
Turku, 20100
-
Finland
France
Novartis Investigative Site
-
LILLE Cédex, 59037
-
France
Novartis Investigative Site
-
Marseille, 13385
-
France
Novartis Investigative Site
-
Nice, 06003
-
France
Germany
Novartis Investigative Site
-
Berlin, 10435
-
Germany
Novartis Investigative Site
-
Berlin, 13353
-
Germany
Novartis Investigative Site
-
Bielefeld, D 33647
-
Germany
Novartis Investigative Site
-
Bochum, 44787
-
Germany
Novartis Investigative Site
-
Erlangen, 91054
-
Germany
Novartis Investigative Site
-
Essen, 45147
-
Germany
Novartis Investigative Site
-
Hamburg, 20251
-
Germany
Novartis Investigative Site
-
Kiel, 24149
-
Germany
Novartis Investigative Site
-
Leipzig, 04107
-
Germany
Novartis Investigative Site
-
Muenchen, 81377
-
Germany
Novartis Investigative Site
-
Tübingen, 72076
-
Germany
Novartis Investigative Site
-
Wiesbaden, 65191
-
Germany
Greece
Novartis Investigative Site
-
Athens, 115 25
GR
Greece
Novartis Investigative Site
-
Glyfada, 16675
-
Greece
Novartis Investigative Site
-
Maroussi, 15125
-
Greece
Italy
Novartis Investigative Site
-
Bologna, 40139
BO
Italy
Novartis Investigative Site
-
Firenze, 50139
FI
Italy
Novartis Investigative Site
-
Roma, 00189
RM
Italy
Novartis Investigative Site
-
Milano, 20133
-
Italy
Novartis Investigative Site
-
Napoli, 80138
-
Italy
Novartis Investigative Site
-
Palermo, 90127
-
Italy
Netherlands
Novartis Investigative Site
-
Sittard-Geleen, 6162 BG
BG
Netherlands
Novartis Investigative Site
-
Leiden, 2333 ZA
-
Netherlands
Novartis Investigative Site
-
Nijmegen, 6532 SZ
-
Netherlands
Norway
Novartis Investigative Site
-
Hamar, 2317
-
Norway
Novartis Investigative Site
-
Sandvika, 1337
-
Norway
Spain
Novartis Investigative Site
-
Santander, 39008
Cantabria
Spain
Novartis Investigative Site
-
Valladolid, 47011
Castilla Y Leon
Spain
Novartis Investigative Site
-
Barcelona, 08035
Cataluna
Spain
Novartis Investigative Site
-
Fuenlabrada, 28942
Madrid
Spain
Novartis Investigative Site
-
Pozuelo de Alarcon, 28223
Madrid
Spain
Novartis Investigative Site
-
Zaragoza, 50009
-
Spain
Sweden
Novartis Investigative Site
-
Helsingborg, 252 21
-
Sweden
Novartis Investigative Site
-
Stockholm, 114 33
-
Sweden
Novartis Investigative Site
-
Uppsala, SE-751 85
-
Sweden
Novartis Investigative Site
-
Vallingby, 162 68
-
Sweden
Switzerland
Novartis Investigative Site
-
Bad Zurzach, 5330
-
Switzerland
Novartis Investigative Site
-
Lausanne, 1011
-
Switzerland
Novartis Investigative Site
-
Zollikon, 8702
-
Switzerland
United Kingdom
Novartis Investigative Site
-
Brighton, BN2 5BE
East Sussex
United Kingdom
Novartis Investigative Site
-
Stoke on Trent, ST46QG
Staffordshire
United Kingdom
Novartis Investigative Site
-
London, SE5 9RS
-
United Kingdom

Have a question?

Call 1-999-669-6682 or email [email protected]