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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03096834




Registration number
NCT03096834
Ethics application status
Date submitted
17/03/2017
Date registered
30/03/2017
Date last updated
4/10/2019

Titles & IDs
Public title
A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies
Scientific title
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
Secondary ID [1] 0 0
2016-002211-18
Secondary ID [2] 0 0
CAMG334A2301
Universal Trial Number (UTN)
Trial acronym
LIBERTY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Episodic Migraine 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - AMG334 Pre-Filled Syringe (PFS)
Other interventions - Placebo Pre-Filled Syringe (PFS)

Placebo Comparator: Placebo - Matching placebo injection, subcutaneous

Experimental: AMG 334 - AMG 334 injection, subcutaneous


Other interventions: AMG334 Pre-Filled Syringe (PFS)
subcutaneous injection of AMG 334

Other interventions: Placebo Pre-Filled Syringe (PFS)
Subcutaneous injection of placebo

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients with a 50% response in the reduction of Monthly Migraine Days (MMD) - Assessed via patient report collected in the headache e-diary.
Timepoint [1] 0 0
The last month (Month 3) of the Double-Blind Treatment Epoch (DBTE)
Secondary outcome [1] 0 0
Change in the number of monthly migraine days (MMDs) from baseline to month 3
Timepoint [1] 0 0
Baseline, the last month (Month 3) of the Double-Blind Treatment Epoch (DBTE)
Secondary outcome [2] 0 0
Change in the Migraine Physical Function Impact Diary (MPFID) "impact on everyday activities" domain score from baseline to month 3
Timepoint [2] 0 0
Baseline, month 3 of the DBTE
Secondary outcome [3] 0 0
Change in the MPFID "physical impairment" domain score from baseline to month 3
Timepoint [3] 0 0
Baseline, month 3 of the DBTE
Secondary outcome [4] 0 0
Change in the number of monthly acute migraine-specific medication treatment days
Timepoint [4] 0 0
Baseline, last month (Month 3) of the Double-Blind Treatment Epoch (DBTE)
Secondary outcome [5] 0 0
Percentage of patients with a 75% response - Assessed via patient report collected in the headache e-diary.
Timepoint [5] 0 0
Baseline, last month (Month 3) of the Double-Blind Treatment Epoch (DBTE)
Secondary outcome [6] 0 0
Percentage of patients with a 100% response - Assessed via patient report collected in the headache e-diary.
Timepoint [6] 0 0
Baseline, last month (Month 3) of the Double-Blind Treatment Epoch (DBTE)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussel
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Hasselt
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Czechia
State/province [7] 0 0
CZE
Country [8] 0 0
Czechia
State/province [8] 0 0
Czech Republic
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha 4
Country [10] 0 0
Denmark
State/province [10] 0 0
Glostrup
Country [11] 0 0
Finland
State/province [11] 0 0
Helsinki
Country [12] 0 0
Finland
State/province [12] 0 0
Turku
Country [13] 0 0
France
State/province [13] 0 0
LILLE Cédex
Country [14] 0 0
France
State/province [14] 0 0
Marseille
Country [15] 0 0
France
State/province [15] 0 0
Nice
Country [16] 0 0
France
State/province [16] 0 0
Paris cedex 10
Country [17] 0 0
France
State/province [17] 0 0
Rouen
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Bielefeld
Country [20] 0 0
Germany
State/province [20] 0 0
Bochum
Country [21] 0 0
Germany
State/province [21] 0 0
Erlangen
Country [22] 0 0
Germany
State/province [22] 0 0
Essen
Country [23] 0 0
Germany
State/province [23] 0 0
Halle
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Germany
State/province [25] 0 0
Kiel
Country [26] 0 0
Germany
State/province [26] 0 0
Leipzig
Country [27] 0 0
Germany
State/province [27] 0 0
Muenchen
Country [28] 0 0
Germany
State/province [28] 0 0
Seesen
Country [29] 0 0
Germany
State/province [29] 0 0
Tübingen
Country [30] 0 0
Germany
State/province [30] 0 0
Wiesbaden
Country [31] 0 0
Greece
State/province [31] 0 0
GR
Country [32] 0 0
Greece
State/province [32] 0 0
Glyfada
Country [33] 0 0
Greece
State/province [33] 0 0
Maroussi
Country [34] 0 0
Italy
State/province [34] 0 0
BO
Country [35] 0 0
Italy
State/province [35] 0 0
FI
Country [36] 0 0
Italy
State/province [36] 0 0
RM
Country [37] 0 0
Italy
State/province [37] 0 0
Milano
Country [38] 0 0
Italy
State/province [38] 0 0
Napoli
Country [39] 0 0
Italy
State/province [39] 0 0
Palermo
Country [40] 0 0
Netherlands
State/province [40] 0 0
BG
Country [41] 0 0
Netherlands
State/province [41] 0 0
Amsterdam
Country [42] 0 0
Netherlands
State/province [42] 0 0
Leiden
Country [43] 0 0
Netherlands
State/province [43] 0 0
Nijmegen
Country [44] 0 0
Norway
State/province [44] 0 0
Hamar
Country [45] 0 0
Norway
State/province [45] 0 0
Oslo
Country [46] 0 0
Spain
State/province [46] 0 0
Andalucia
Country [47] 0 0
Spain
State/province [47] 0 0
Cantabria
Country [48] 0 0
Spain
State/province [48] 0 0
Castilla Y Leon
Country [49] 0 0
Spain
State/province [49] 0 0
Cataluna
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Zaragoza
Country [53] 0 0
Sweden
State/province [53] 0 0
Helsingborg
Country [54] 0 0
Sweden
State/province [54] 0 0
Stockholm
Country [55] 0 0
Sweden
State/province [55] 0 0
Uppsala
Country [56] 0 0
Sweden
State/province [56] 0 0
Vallingby
Country [57] 0 0
Switzerland
State/province [57] 0 0
Bad Zurzach
Country [58] 0 0
Switzerland
State/province [58] 0 0
Lausanne
Country [59] 0 0
Switzerland
State/province [59] 0 0
Zollikon
Country [60] 0 0
United Kingdom
State/province [60] 0 0
East Sussex
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Staffordshire
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Glasgow
Country [63] 0 0
United Kingdom
State/province [63] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03096834
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications