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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03096834
Ethics application status
Date submitted
17/03/2017
Date registered
30/03/2017

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 140 mg AMG 334 Against Placebo in Adult Episodic Migraine Patients Who Have Failed 2-4 Prophylactic Treatments (LIBERTY)
Secondary ID [1] 0 0
2016-002211-18
Secondary ID [2] 0 0
CAMG334A2301
Universal Trial Number (UTN)
Trial acronym
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
Treatment: Other - AMG334 (70 mg) Pre-Filled Syringe (PFS)
Treatment: Other - Placebo Pre-Filled Syringe (PFS)

Placebo comparator: Placebo DB - Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch

Experimental: AMG334 140 mg DB - AMG334 70 mg subcutaneous injections (2) administered every 4 weeks during Double-Blind Epoch

Experimental: AMG334 140 mg DB cont on AMG334 140 mg - AMG334 70 mg subcutaneous injections (2) during DB continued on AMG334 140 mg in Open-Label Epoch

Experimental: Placebo in DB to AMG334 140 mg - Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch


Treatment: Other: AMG334 (70 mg) Pre-Filled Syringe (PFS)
Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection

Treatment: Other: Placebo Pre-Filled Syringe (PFS)
Subcutaneous injection of matching placebo
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
Timepoint [1] 0 0
Baseline, Month 3 (last 4 weeks of treatment)
Secondary outcome [1] 0 0
Change From Baseline in Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
Timepoint [1] 0 0
Baseline, Month 3 (last 4 weeks of treatment)
Secondary outcome [2] 0 0
Change From Baseline in Physical Impairment and Everyday Activities as Measured by the Migraine Physical Function Impact Diary (MPFID) at Month 3
Timepoint [2] 0 0
Baseline, Month 3 (last 4 weeks of treatment)
Secondary outcome [3] 0 0
Change in the Number of Monthly Acute Migraine-specific Medication Treatment Days at Month 3
Timepoint [3] 0 0
Baseline, Month 3 (last 4 weeks of treatment)
Secondary outcome [4] 0 0
Percentage of Participants With a 75% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
Timepoint [4] 0 0
Baseline, Month 3 (last 4 weeks of treatment)
Secondary outcome [5] 0 0
Percentage of Participants With a 100% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
Timepoint [5] 0 0
Baseline, Month 3 (last 4 weeks of treatment)
Secondary outcome [6] 0 0
Number of Participants Who Developed Anti-AMG334 Antibodies
Timepoint [6] 0 0
Baseline up to approximately 180 weeks

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
Sex
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 over 19 on Beck Depression Inventory-2
* 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/01/2021
Sample size
Target
Accrual to date
Final
246
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 Cedex
Country [14] 0 0
France
State/province [14] 0 0
Marseille Cedex 05
Country [15] 0 0
France
State/province [15] 0 0
Nice
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Germany
State/province [17] 0 0
Bielefeld
Country [18] 0 0
Germany
State/province [18] 0 0
Bochum
Country [19] 0 0
Germany
State/province [19] 0 0
Erlangen
Country [20] 0 0
Germany
State/province [20] 0 0
Essen
Country [21] 0 0
Germany
State/province [21] 0 0
Hamburg
Country [22] 0 0
Germany
State/province [22] 0 0
Kiel
Country [23] 0 0
Germany
State/province [23] 0 0
Leipzig
Country [24] 0 0
Germany
State/province [24] 0 0
Muenchen
Country [25] 0 0
Germany
State/province [25] 0 0
Tübingen
Country [26] 0 0
Germany
State/province [26] 0 0
Wiesbaden
Country [27] 0 0
Greece
State/province [27] 0 0
GR
Country [28] 0 0
Greece
State/province [28] 0 0
Glyfada
Country [29] 0 0
Greece
State/province [29] 0 0
Maroussi
Country [30] 0 0
Italy
State/province [30] 0 0
BO
Country [31] 0 0
Italy
State/province [31] 0 0
FI
Country [32] 0 0
Italy
State/province [32] 0 0
RM
Country [33] 0 0
Italy
State/province [33] 0 0
Milano
Country [34] 0 0
Italy
State/province [34] 0 0
Napoli
Country [35] 0 0
Italy
State/province [35] 0 0
Palermo
Country [36] 0 0
Netherlands
State/province [36] 0 0
BG
Country [37] 0 0
Netherlands
State/province [37] 0 0
Leiden
Country [38] 0 0
Netherlands
State/province [38] 0 0
Nijmegen
Country [39] 0 0
Norway
State/province [39] 0 0
Hamar
Country [40] 0 0
Norway
State/province [40] 0 0
Sandvika
Country [41] 0 0
Spain
State/province [41] 0 0
Cantabria
Country [42] 0 0
Spain
State/province [42] 0 0
Castilla Y Leon
Country [43] 0 0
Spain
State/province [43] 0 0
Catalunya
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid
Country [45] 0 0
Spain
State/province [45] 0 0
Zaragoza
Country [46] 0 0
Sweden
State/province [46] 0 0
Lund
Country [47] 0 0
Sweden
State/province [47] 0 0
Stockholm
Country [48] 0 0
Sweden
State/province [48] 0 0
Uppsala
Country [49] 0 0
Sweden
State/province [49] 0 0
Vallingby
Country [50] 0 0
Switzerland
State/province [50] 0 0
Bad Zurzach
Country [51] 0 0
Switzerland
State/province [51] 0 0
Lausanne
Country [52] 0 0
Switzerland
State/province [52] 0 0
Zollikon
Country [53] 0 0
United Kingdom
State/province [53] 0 0
East Sussex
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Staffordshire
Country [55] 0 0
United Kingdom
State/province [55] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03096834