A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies

NCT03096834 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CAMG334A23012016-002211-18
• Study Type: interventional
• Target: 246
• Locations: 15 countries
• Sites: 58

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.

Conditions

Episodic Migraine

Keywords

Migraine; attack; headache; episodic; aura; AMG 334; CGRP receptor agonist; erenumab; adult

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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

  Baseline, Month 3 (last 4 weeks of treatment)

• Change in the Number of Monthly Acute Migraine-specific Medication Treatment Days at Month 3

  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)

  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)

  Baseline, Month 3 (last 4 weeks of treatment)

Study Arms (4)

Placebo DB

PLACEBO COMPARATOR

Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch

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

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

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

Biological: AMG334 (70 mg) Pre-Filled Syringe (PFS)

Interventions

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

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) BIOLOGICAL

Subcutaneous injection of matching placebo

Placebo DB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented history of migraine in the 12 months prior to screen
• days per month of migraine symptoms
• \>=80% diary compliance during the Baseline period
• Failure of previous migraine prophylactic treatments

You may not qualify if:

• \>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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (59)

Novartis Investigative Site

Heidelberg, 3084, Australia

Location

Novartis Investigative Site

Innsbruck, A 6020, Austria

Location

Novartis Investigative Site

Vienna, 1090, Austria

Location

Novartis Investigative Site

Brussels, 1090, Belgium

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Hasselt, 3500, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Prague, CZE, 120 00, Czechia

Location

Novartis Investigative Site

Czech Republic, 18600, Czechia

Location

Novartis Investigative Site

Prague, 140 59, Czechia

Location

Novartis Investigative Site

Glostrup Municipality, 2600, Denmark

Location

Novartis Investigative Site

Helsinki, 00180, Finland

Location

Novartis Investigative Site

Helsinki, 00930, Finland

Location

Novartis Investigative Site

Turku, 20100, Finland

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Marseille, 13885, France

Location

Novartis Investigative Site

Nice, 06003, France

Location

Novartis Investigative Site

Berlin, 10435, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Bielefeld, D 33647, Germany

Location

Novartis Investigative Site

Bochum, 44787, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Hamburg, 20251, Germany

Location

Novartis Investigative Site

Kiel, 24149, Germany

Location

Novartis Investigative Site

Leipzig, 04107, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Wiesbaden, 65191, Germany

Location

Novartis Investigative Site

Athens, GR, 115 25, Greece

Location

Novartis Investigative Site

Glyfada, 16675, Greece

Location

Novartis Investigative Site

Marousi, 15125, Greece

Location

Novartis Investigative Site

Bologna, BO, 40139, Italy

Location

Novartis Investigative Site

Florence, FI, 50139, Italy

Location

Novartis Investigative Site

Roma, RM, 00189, Italy

Location

Novartis Investigative Site

Milan, 20133, Italy

Location

Novartis Investigative Site

Napoli, 80138, Italy

Location

Novartis Investigative Site

Palermo, 90127, Italy

Location

Novartis Investigative Site

Sittard-Geleen, BG, 6162 BG, Netherlands

Location

Novartis Investigative Site

Leiden, 2333 ZA, Netherlands

Location

Novartis Investigative Site

Nijmegen, 6532 SZ, Netherlands

Location

Novartis Investigative Site

Hamar, 2317, Norway

Location

Novartis Investigative Site

Sandvika, 1337, Norway

Location

Novartis Investigative Site

Santander, Cantabria, 39008, Spain

Location

Novartis Investigative Site

Valladolid, Castille and León, 47011, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Fuenlabrada, Madrid, 28942, Spain

Location

Novartis Investigative Site

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Novartis Investigative Site

Zaragoza, 50009, Spain

Location

Novartis Investigative Site

Lund, 222 22, Sweden

Location

Novartis Investigative Site

Stockholm, 114 33, Sweden

Location

Novartis Investigative Site

Uppsala, SE-751 85, Sweden

Location

Novartis Investigative Site

Vällingby, 162 68, Sweden

Location

Novartis Investigative Site

Bad Zurzach, 5330, Switzerland

Location

Novartis Investigative Site

Lausanne, 1011, Switzerland

Location

Novartis Investigative Site

Zollikon, 8702, Switzerland

Location

Novartis Investigative Site

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

Novartis Investigative Site

Stoke-on-Trent, Staffordshire, ST46QG, United Kingdom

Location

Novartis Investigative Site

London, SE5 9RS, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 38669638 DERIVED

• Lampl 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.

  PMID: 35978286 DERIVED

• Ferrari 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.

  PMID: 34845002 DERIVED

• Goadsby 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.

  PMID: 33910942 DERIVED

• Lanteri-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.

  PMID: 33402419 DERIVED

• Reuter 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.

  PMID: 30360965 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache; Recurrence; Epilepsy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 30, 2017
• Study Start: March 20, 2017
• Primary Completion: January 18, 2018
• Study Completion: January 28, 2021
• Last Updated: March 23, 2022
• Results First Posted: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

AU (2); FR (3); GB (3); DE (12); GR (3); NO (2); CH (3); NL (3); CZ (3); DK (1); BE (4); IT (6); FI (3); ES (6); SE (4)