Episodic MigrainePhase 3NCT03096834
A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies
A Phase 3 study testing AMG334 (70 mg) Pre-Filled Syringe (PFS) in people with Episodic Migraine, run by Novartis Pharmaceuticals at 59 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Episodic Migraine
- What is being tested?
- AMG334 (70 mg) Pre-Filled Syringe (PFS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 59 sitesin 16 countries
- Study dates
- 20 Mar 2017to 28 Jan 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- >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
Trial locations and contacts
59 sites in 16 countries.
59 sites in 16 countries
Germany12 sites
Novartis Investigative Site
Berlin, 10435
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Bielefeld, D 33647
Novartis Investigative Site
Bochum, 44787
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Hamburg, 20251
Novartis Investigative Site
Kiel, 24149
Novartis Investigative Site
Leipzig, 04107
Novartis Investigative Site
München, 81377
Novartis Investigative Site
Tübingen, 72076
Novartis Investigative Site
Wiesbaden, 65191
Italy6 sites
Novartis Investigative Site
Bologna, BO, 40139
Novartis Investigative Site
Florence, FI, 50139
Novartis Investigative Site
Milan, 20133
Novartis Investigative Site
Naples, 80138
Novartis Investigative Site
Palermo, 90127
Novartis Investigative Site
Roma, RM, 00189
Spain6 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Fuenlabrada, Madrid, 28942
Novartis Investigative Site
Pozuelo de Alarcón, Madrid, 28223
Novartis Investigative Site
Santander, Cantabria, 39008
Novartis Investigative Site
Valladolid, Castille and León, 47011
Novartis Investigative Site
Zaragoza, 50009
Belgium4 sites
Novartis Investigative Site
Brussels, 1090
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Hasselt, 3500
Novartis Investigative Site
Leuven, 3000
Sweden4 sites
Novartis Investigative Site
Lund, 222 22
Novartis Investigative Site
Stockholm, 114 33
Novartis Investigative Site
Uppsala, SE-751 85
Novartis Investigative Site
Vällingby, 162 68
Czechia3 sites
Novartis Investigative Site
Czech Republic, 18600
Novartis Investigative Site
Prague, CZE, 120 00
Novartis Investigative Site
Prague, 140 59
Finland3 sites
Novartis Investigative Site
Helsinki, 00180
Novartis Investigative Site
Helsinki, 00930
Novartis Investigative Site
Turku, 20100
France3 sites
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Marseille, 13885
Novartis Investigative Site
Nice, 06003
Greece3 sites
Novartis Investigative Site
Athens, GR, 115 25
Novartis Investigative Site
Glyfada, 16675
Novartis Investigative Site
Marousi, 15125
Netherlands3 sites
Novartis Investigative Site
Leiden, 2333 ZA
Novartis Investigative Site
Nijmegen, 6532 SZ
Novartis Investigative Site
Sittard-Geleen, BG, 6162 BG
Switzerland3 sites
Novartis Investigative Site
Bad Zurzach, 5330
Novartis Investigative Site
Lausanne, 1011
Novartis Investigative Site
Zollikon, 8702
United Kingdom3 sites
Novartis Investigative Site
Brighton, East Sussex, BN2 5BE
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
Stoke-on-Trent, Staffordshire, ST46QG
Austria2 sites
Novartis Investigative Site
Innsbruck, A 6020
Novartis Investigative Site
Vienna, 1090
Norway2 sites
Novartis Investigative Site
Hamar, 2317
Novartis Investigative Site
Sandvika, 1337
About this study
Official 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)
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.
Read the detailed description
This study was a double blind, placebo-controlled, randomized trial in adult patients with episodic migraine. There was a screening period of 2 weeks to assess initial eligibility, and a 4-week baseline period. After randomization, participants entered the double-blind treatment epoch (DBTE) and had clinic visits for 12 weeks. All participants who completed the DBTE were eligible to enter the Open-Label Treatment Epoch (OLTE) for up to 156 weeks. All participants had a 12 week Follow-Up Epoch and a a Follow-Up visit 16 weeks after the last dose of AMG334 unless the participant continued on commercially available AMG334. Participants who had demonstrated clinical benefit were eligible to enter a Post Trial Access (PTA-Open Label Treatment Epoch) of flexible duration for approximately 6 months.
- Conditions
- Episodic Migraine
- Being tested
- AMG334 (70 mg) Pre-Filled Syringe (PFS), Placebo Pre-Filled Syringe (PFS)
- Keywords
- Migraine, attack, headache, episodic, aura, AMG 334, CGRP receptor agonist, erenumab, adult
- Medical subject headings
- Migraine Disorders, Headache, Recurrence, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG334 (70 mg) Pre-Filled Syringe (PFS)Biological
Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection
Placebo Pre-Filled Syringe (PFS)Biological
Subcutaneous injection of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo DB | Placebo comparator | Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch Receives: Biological: Placebo Pre-Filled Syringe (PFS) |
| AMG334 140 mg DB | Experimental | AMG334 70 mg subcutaneous injections (2) administered every 4 weeks during Double-Blind Epoch Receives: Biological: AMG334 (70 mg) Pre-Filled Syringe (PFS) |
| AMG334 140 mg DB cont on AMG334 140 mg | Experimental | AMG334 70 mg subcutaneous injections (2) during DB continued on AMG334 140 mg in Open-Label Epoch Receives: Biological: AMG334 (70 mg) Pre-Filled Syringe (PFS) |
| Placebo in DB to AMG334 140 mg | Experimental | Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch Receives: Biological: AMG334 (70 mg) Pre-Filled Syringe (PFS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
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.
Measured: Baseline, Month 3 (last 4 weeks of treatment)
Secondary outcomes (6)
Change From Baseline in Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
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.
Measured: Baseline, Month 3 (last 4 weeks of treatment)
Change From Baseline in Physical Impairment and Everyday Activities as Measured by the Migraine Physical Function Impact Diary (MPFID) at Month 3
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)
Measured: Baseline, Month 3 (last 4 weeks of treatment)
Change in the Number of Monthly Acute Migraine-specific Medication Treatment Days at Month 3
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.
Measured: Baseline, Month 3 (last 4 weeks of treatment)
Percentage of Participants With a 75% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
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.
Measured: Baseline, Month 3 (last 4 weeks of treatment)
Percentage of Participants With a 100% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
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.
Measured: Baseline, Month 3 (last 4 weeks of treatment)
Number of Participants Who Developed Anti-AMG334 Antibodies
Blood samples for immunogenicity testing were collected for the measurement of anti-AMG334 binding antibodies.
Measured: Baseline up to approximately 180 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start20 Mar 2017
- Primary completion18 Jan 2018
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Episodic MigraineStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096834
- Sponsor's protocol ID
- CAMG334A2301
- Other IDs
- 2016-002211-18, 2016
- Status last verified
- Feb 2022
- First submitted
- 17 Mar 2017
- Last updated
- 23 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Reuter U, Goadsby PJ, Ferrari MD, Da Silva Lima GP, Mondal S, Kalim J, Hasan F, Wen S, Arkuszewski M, Pandhi S, Stites T, Lanteri-Minet M. Efficacy and Safety of Erenumab in Participants With Episodic Migraine in Whom 2-4 Prior Preventive Treatments Had Failed: LIBERTY 3-Year Study. Neurology. 2024 May;102(10):e209349. doi: 10.1212/WNL.0000000000209349. Epub 2024 Apr 26.
PubMed 38669638Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.
PubMed 35978286Ferrari MD, Reuter U, Goadsby PJ, Paiva da Silva Lima G, Mondal S, Wen S, Tenenbaum N, Pandhi S, Lanteri-Minet M, Stites T. Two-year efficacy and safety of erenumab in participants with episodic migraine and 2-4 prior preventive treatment failures: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2022 Mar;93(3):254-262. doi: 10.1136/jnnp-2021-327480. Epub 2021 Nov 29.
PubMed 34845002Goadsby PJ, Reuter U, Lanteri-Minet M, Paiva da Silva Lima G, Hours-Zesiger P, Fernandes C, Wen S, Tenenbaum N, Kataria A, Ferrari MD, Klatt J. Long-term Efficacy and Safety of Erenumab: Results From 64 Weeks of the LIBERTY Study. Neurology. 2021 May 31;96(22):e2724-e2735. doi: 10.1212/WNL.0000000000012029.
PubMed 33910942Lanteri-Minet M, Goadsby PJ, Reuter U, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2-4 preventives were not useful: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2021 May;92(5):466-472. doi: 10.1136/jnnp-2020-324396. Epub 2021 Jan 5.
PubMed 33402419Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280-2287. doi: 10.1016/S0140-6736(18)32534-0. Epub 2018 Oct 22.
PubMed 30360965
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03096834
- Acronym / sponsor ID
- CAMG334A2301
- Conditions
- Episodic Migraine
- Keywords
- Migraine, attack, headache, episodic, aura, AMG 334, CGRP receptor agonist, erenumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Posted 18 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was a double blind, placebo-controlled, randomized trial in adult patients with episodic migraine. There was a screening period of 2 weeks to assess initial eligibility, and a 4-week baseline period. After randomization, participants entered the double-blind treatment epoch (DBTE) and had clinic visits for 12 weeks. All participants who completed the DBTE were eligible to enter the Open-Label Treatment Epoch (OLTE) for up to 156 weeks. All participants had a 12 week Follow-Up Epoch and a a Follow-Up visit 16 weeks after the last dose of AMG334 unless the participant continued on commercially available AMG334. Participants who had demonstrated clinical benefit were eligible to enter a Post Trial Access (PTA-Open Label Treatment Epoch) of flexible duration for approximately 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo DB | Placebo comparator | Biological: Placebo Pre-Filled Syringe (PFS)Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch |
| AMG334 140 mg DB | Experimental | Biological: AMG334 (70 mg) Pre-Filled Syringe (PFS)AMG334 70 mg subcutaneous injections (2) administered every 4 weeks during Double-Blind Epoch |
| AMG334 140 mg DB cont on AMG334 140 mg | Experimental | Biological: AMG334 (70 mg) Pre-Filled Syringe (PFS)AMG334 70 mg subcutaneous injections (2) during DB continued on AMG334 140 mg in Open-Label Epoch |
| Placebo in DB to AMG334 140 mg | Experimental | Biological: AMG334 (70 mg) Pre-Filled Syringe (PFS)Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- >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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | AMG334 140 mg DB, AMG334 140 mg DB cont on AMG334 140 mg, Placebo in DB to AMG334 140 mg |
| Placebo Pre-Filled Syringe (PFS)Subcutaneous injection of matching placebo | Biological | Placebo DB |
Primary outcome
Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
Time frame: Baseline, Month 3 (last 4 weeks of treatment)
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.
6 secondary outcomes
Change From Baseline in Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
Time frame: Baseline, Month 3 (last 4 weeks of treatment)
Change From Baseline in Physical Impairment and Everyday Activities as Measured by the Migraine Physical Function Impact Diary (MPFID) at Month 3
Time frame: Baseline, Month 3 (last 4 weeks of treatment)
Change in the Number of Monthly Acute Migraine-specific Medication Treatment Days at Month 3
Time frame: Baseline, Month 3 (last 4 weeks of treatment)
Percentage of Participants With a 75% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
Time frame: Baseline, Month 3 (last 4 weeks of treatment)
Percentage of Participants With a 100% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
Time frame: Baseline, Month 3 (last 4 weeks of treatment)
Number of Participants Who Developed Anti-AMG334 Antibodies
Time frame: Baseline up to approximately 180 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38669638Reuter U, Goadsby PJ, Ferrari MD, Da Silva Lima GP, Mondal S, Kalim J, Hasan F, Wen S, Arkuszewski M, Pandhi S, Stites T, Lanteri-Minet M. Efficacy and Safety of Erenumab in Participants With Episodic Migraine in Whom 2-4 Prior Preventive Treatments Had Failed: LIBERTY 3-Year Study. Neurology. 2024 May;102(10):e209349. doi: 10.1212/WNL.0000000000209349. Epub 2024 Apr 26.
- Derived from this study: PubMed 35978286Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.
- Derived from this study: PubMed 34845002Ferrari MD, Reuter U, Goadsby PJ, Paiva da Silva Lima G, Mondal S, Wen S, Tenenbaum N, Pandhi S, Lanteri-Minet M, Stites T. Two-year efficacy and safety of erenumab in participants with episodic migraine and 2-4 prior preventive treatment failures: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2022 Mar;93(3):254-262. doi: 10.1136/jnnp-2021-327480. Epub 2021 Nov 29.
- Derived from this study: PubMed 33910942Goadsby PJ, Reuter U, Lanteri-Minet M, Paiva da Silva Lima G, Hours-Zesiger P, Fernandes C, Wen S, Tenenbaum N, Kataria A, Ferrari MD, Klatt J. Long-term Efficacy and Safety of Erenumab: Results From 64 Weeks of the LIBERTY Study. Neurology. 2021 May 31;96(22):e2724-e2735. doi: 10.1212/WNL.0000000000012029.
- Derived from this study: PubMed 33402419Lanteri-Minet M, Goadsby PJ, Reuter U, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2-4 preventives were not useful: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2021 May;92(5):466-472. doi: 10.1136/jnnp-2020-324396. Epub 2021 Jan 5.
- Derived from this study: PubMed 30360965Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280-2287. doi: 10.1016/S0140-6736(18)32534-0. Epub 2018 Oct 22.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
59 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AMG334 (70 mg) Pre-Filled Syringe (PFS) in people with Episodic Migraine, run by Novartis Pharmaceuticals at 59 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Germany, Italy, Spain, Belgium, Sweden and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) (time frame: Baseline, Month 3 (last 4 weeks of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03096834, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.