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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03096834
Registration number
NCT03096834
Ethics application status
Date submitted
17/03/2017
Date registered
30/03/2017
Date last updated
23/03/2022
Titles & IDs
Public title
A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies
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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)
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Secondary ID [1]
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2016-002211-18
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Secondary ID [2]
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CAMG334A2301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Episodic Migraine
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - AMG334 (70 mg) Pre-Filled Syringe (PFS)
Other interventions - 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
Other interventions: 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
Other interventions: Placebo Pre-Filled Syringe (PFS)
Subcutaneous injection of matching placebo
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
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Assessment method [1]
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A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting = 30 minutes with at least 1 criteria: 1. = 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. = 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.
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Timepoint [1]
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Baseline, Month 3 (last 4 weeks of treatment)
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Secondary outcome [1]
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Change From Baseline in Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
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Assessment method [1]
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A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting = 30 minutes with at least 1 criteria: 1. = 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. = 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.
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Timepoint [1]
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Baseline, Month 3 (last 4 weeks of treatment)
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Secondary outcome [2]
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Change From Baseline in Physical Impairment and Everyday Activities as Measured by the Migraine Physical Function Impact Diary (MPFID) at Month 3
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Assessment method [2]
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MPFID has 2 domains: Everyday Activities, which consisted of 7 items and Physical Impairment with 5 items using a 5-point scale. Scores were summed across each domain and were then transformed and used for analyses. Transforming MPFID domain scores ranged from 0-100, where higher scores were indicative of greater migraine impact (ie, higher burden)
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Timepoint [2]
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Baseline, Month 3 (last 4 weeks of treatment)
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Secondary outcome [3]
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Change in the Number of Monthly Acute Migraine-specific Medication Treatment Days at Month 3
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Assessment method [3]
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Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications included two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline was the number of migraine-specific medication treatment days in the baseline period.
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Timepoint [3]
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Baseline, Month 3 (last 4 weeks of treatment)
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Secondary outcome [4]
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Percentage of Participants With a 75% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
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Assessment method [4]
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A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting = 30 minutes with at least 1 criteria: 1. = 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. = 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.
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Timepoint [4]
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Baseline, Month 3 (last 4 weeks of treatment)
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Secondary outcome [5]
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Percentage of Participants With a 100% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
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Assessment method [5]
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A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting = 30 minutes with at least 1 criteria: 1. = 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. = 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.
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Timepoint [5]
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Baseline, Month 3 (last 4 weeks of treatment)
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Secondary outcome [6]
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Number of Participants Who Developed Anti-AMG334 Antibodies
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Assessment method [6]
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Blood samples for immunogenicity testing were collected for the measurement of anti-AMG334 binding antibodies.
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Timepoint [6]
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Baseline up to approximately 180 weeks
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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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/03/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/01/2021
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Sample size
Target
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Accrual to date
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Final
246
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigative Site - Heidelberg
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Innsbruck
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Austria
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Vienna
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Belgium
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Brussel
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Leuven
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Country [7]
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Czechia
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CZE
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Czechia
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Czech Republic
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Czechia
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State/province [9]
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Praha 4
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Denmark
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Glostrup
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Finland
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Helsinki
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Finland
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Turku
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France
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Lille Cedex
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France
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Marseille Cedex 05
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France
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Nice
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Germany
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Berlin
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Germany
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Bielefeld
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Germany
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Bochum
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Leipzig
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Germany
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Muenchen
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Germany
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Tübingen
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Germany
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Wiesbaden
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Greece
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GR
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Greece
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Glyfada
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Greece
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Maroussi
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Italy
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BO
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Italy
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FI
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Italy
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RM
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Italy
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Milano
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Italy
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Napoli
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Italy
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Palermo
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BG
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Leiden
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Nijmegen
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Norway
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Hamar
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Norway
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Sandvika
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Catalunya
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Madrid
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Spain
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Zaragoza
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Uppsala
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Sweden
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Vallingby
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Switzerland
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Bad Zurzach
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Switzerland
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Lausanne
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Switzerland
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Zollikon
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United Kingdom
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East Sussex
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United Kingdom
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Staffordshire
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine if AMG 334 is effective in treating migraines in
patients who have failed other preventive migraine treatments.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03096834
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03096834
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