A study to evaluate the effects of AMG334 compared to placebo medication in the prophylactic treatment of migraine in adult patients who have already tried other prophylactic migraine treatments unsuccessfully

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002211-18-CZ

Enrollment

220

Registered

2016-07-29

Start date

2016-10-31

Completion date

Unknown

Last updated

2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Prevention MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Code: AMG334 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not applicable CAS Number: 1582205-90-0 Current Sponsor code: AMG334 Other descriptive name: AMG334 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Documented history of migraine (with or without aura) for = 12 months prior to screening according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) - 4 to 14 days per month of migraine symptoms (based on ICHD-3 criteria) on average across the 3 months prior to screening based on retrospective reporting - =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Older than 50 years of age at migraine onset - Unable to differentiate migraine from other headaches - History of cluster headache or hemiplegic migraine headache - Failed more than 4 prior migraine prophylaxis treatments [as specified in protocol] - Use of a prophylactic migraine medication within 5 half-lives, or a device or procedure within one month prior to the start of the baseline phase or during the baseline phase - Prior Botulinum toxin A treatment in the head/neck region (including cosmetic use or other licensed indications for Botox ®) within 4 months prior to start of or during the baseline phase - Use of the following for any indication in the 1 month prior to the start of the baseline phase or during the baseline phase: o ergotamines or triptanes =10 days/month, or o simple analgesics (NSAIDs, acetaminophen, paracetamol) =15 days/month, or o opioid- or butalbital-containing analgesics =4 days/month

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of AMG 334 compared to placebo on the proportion of patients with at least 50% reduction from baseline in monthly migraine days;Secondary Objective: -To evaluate the effect of AMG 334 compared to placebo on the change from baseline of monthly migraine days -To evaluate the effect of AMG 334 compared to placebo on the "impact on everyday activities" domain as measured by the MPFID; -To evaluate the effect of AMG 334 compared to placebo on the "physical impairment" domain as measured by the Migraine Physical Function Impact Diary (MPFID); -To evaluate the effect of AMG 334 compared to placebo on change from baseline; -To evaluate the effect of AMG 334 compared to placebo on the proportion of patients with at least 75% reduction from baseline in monthly migraine days; -To evaluate the effect of AMG 334 compared to placebo on the proportion of patients with a 100% reduction from baseline in monthly migraine days; -To evaluate the safety, tolerability, and immunogenicity of AMG 334, -To evaluate clinical benefit as assessed by the investigator during the PTA Open-Label Treatment Epoch;Primary end point(s): Achievement of at least a 50% reduction from baseline in monthly migraine days in the last month (month 3) of the double-blind epoch;Timepoint(s) of evaluation of this end point: Month 3	—

Measure

Time frame

Main Objective: To evaluate the effect of AMG 334 compared to placebo on the proportion of patients with at least 50% reduction from baseline in monthly migraine days;Secondary Objective: -To evaluate the effect of AMG 334 compared to placebo on the change from baseline of monthly migraine days -To evaluate the effect of AMG 334 compared to placebo on the "impact on everyday activities" domain as measured by the MPFID; -To evaluate the effect of AMG 334 compared to placebo on the "physical impairment" domain as measured by the Migraine Physical Function Impact Diary (MPFID); -To evaluate the effect of AMG 334 compared to placebo on change from baseline; -To evaluate the effect of AMG 334 compared to placebo on the proportion of patients with at least 75% reduction from baseline in monthly migraine days; -To evaluate the effect of AMG 334 compared to placebo on the proportion of patients with a 100% reduction from baseline in monthly migraine days; -To evaluate the safety, tolerability, and immunogenicity of AMG 334, -To evaluate clinical benefit as assessed by the investigator during the PTA Open-Label Treatment Epoch;Primary end point(s): Achievement of at least a 50% reduction from baseline in monthly migraine days in the last month (month 3) of the double-blind epoch;Timepoint(s) of evaluation of this end point: Month 3

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Secondary

Measure	Time frame
Secondary end point(s): Change from baseline on monthly migraine days in the last month of the double-blind epoch Change from baseline to month 3 of the MPFID "impact on everyday activities" sub-domain score Change from baseline to month 3 of the MPFID "physical impairment" sub-domain score Change from baseline of monthly acute migraine medication treatment days in the last month of the double-blind epoch The achievement of at least a 75% reduction from baseline in monthly migraine days in the last month of the double-blind epoch The achievement of at least a 100% reduction from baseline in monthly migraine days in the last month of the double-blind epoch. Occurrence of cardiovascular events and evaluation of anti-drug antibodies in this patient population Exploratory Open-Label Epochs: additional data in a subset of patients in the PTA-Open-Label Treatment Epoch (anticipated up to an additional 6 months of data);Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol.	—

Measure

Time frame

Secondary end point(s): Change from baseline on monthly migraine days in the last month of the double-blind epoch Change from baseline to month 3 of the MPFID "impact on everyday activities" sub-domain score Change from baseline to month 3 of the MPFID "physical impairment" sub-domain score Change from baseline of monthly acute migraine medication treatment days in the last month of the double-blind epoch The achievement of at least a 75% reduction from baseline in monthly migraine days in the last month of the double-blind epoch The achievement of at least a 100% reduction from baseline in monthly migraine days in the last month of the double-blind epoch. Occurrence of cardiovascular events and evaluation of anti-drug antibodies in this patient population Exploratory Open-Label Epochs: additional data in a subset of patients in the PTA-Open-Label Treatment Epoch (anticipated up to an additional 6 months of data);Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol.

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Countries

Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom

Contacts

Public ContactInformacní služba – klin. hodnocení

Novartis s.r.o.

dotazy.klinickehodnoceni@novartis.com+420 2 25775 111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026