A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies
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ClinicalTrials.gov Identifier: NCT03096834 |
Recruitment Status :
Completed
First Posted : March 30, 2017
Results First Posted : February 18, 2022
Last Update Posted : March 23, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Episodic Migraine | Biological: AMG334 (70 mg) Pre-Filled Syringe (PFS) Biological: Placebo Pre-Filled Syringe (PFS) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 246 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
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) |
Actual Study Start Date : | March 20, 2017 |
Actual Primary Completion Date : | January 18, 2018 |
Actual Study Completion Date : | January 28, 2021 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo DB
Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch
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Biological: Placebo Pre-Filled Syringe (PFS)
Subcutaneous injection of matching placebo |
Experimental: AMG334 140 mg DB
AMG334 70 mg subcutaneous injections (2) administered every 4 weeks during Double-Blind Epoch
|
Biological: 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 |
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
|
Biological: 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 |
Experimental: Placebo in DB to AMG334 140 mg
Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch
|
Biological: 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 |
- 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.
- 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) ]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.
- 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) ]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)
- 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) ]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.
- 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) ]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.
- 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) ]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.
- Number of Participants Who Developed Anti-AMG334 Antibodies [ Time Frame: Baseline up to approximately 180 weeks ]Blood samples for immunogenicity testing were collected for the measurement of anti-AMG334 binding antibodies.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 over 19 on Beck Depression Inventory-2
- Active chronic pain syndrome
- Cardiac or hepatic disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096834

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03096834 |
Other Study ID Numbers: |
CAMG334A2301 2016-002211-18 ( EudraCT Number ) |
First Posted: | March 30, 2017 Key Record Dates |
Results First Posted: | February 18, 2022 |
Last Update Posted: | March 23, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 |
URL: | http://www.clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Migraine attack headache episodic aura |
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