MedPath

Erenumab

Generic Name
Erenumab
Brand Names
Aimovig
Drug Type
Biotech
CAS Number
1582205-90-0
Unique Ingredient Identifier
I5I8VB78VT
Background

Erenumab (AMG-334) (INN; trade name Aimovig) is a human monoclonal antibody designed specifically to bind and antagonize the calcitonin gene-related peptide receptor (CGRPR) as a means to prevent migraines. Aimovig, as released and marketed by Novartis and Amgen, is in fact a novel therapeutic approach as the first and only FDA approved treatment specifically developed to prevent migraine by blocking the CGRP receptor, which is believed to play a critical role in migraine .

In particular, erenumab-aooe is a human immunoglobulin G2 monoclonal antibody that has high affinity binding to the CGRP receptor . The antibody is produced utlilizing recombinant DNA technology in Chinese hamster ovary cells . It is composed of 2 heavy chains, each containing 456 amino acids, and 2 light chains of the lambda subclass, each containing 216 amino acids, with an approximate molecular weight of 150 kDa .

Indication

Erenumab is indicated for the preventative treatment of migraine in adults .

Associated Conditions
Migraine

A Controlled Trial of Erenumab in Migraine Prevention

Phase 3
Completed
Conditions
Migraine
Interventions
Drug: Placebo
First Posted Date
2019-01-23
Last Posted Date
2024-02-21
Lead Sponsor
Amgen
Target Recruit Count
261
Registration Number
NCT03812224
Locations
🇯🇵

Research Site, Kai-shi, Yamanashi, Japan

Imaging the Migraine Brain Pre- and Post-Erenumab

Phase 4
Completed
Conditions
Migraine
Interventions
First Posted Date
2018-12-12
Last Posted Date
2024-01-09
Lead Sponsor
Mayo Clinic
Target Recruit Count
50
Registration Number
NCT03773562
Locations
🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females

Phase 1
Completed
Conditions
Headache, Migraine
Interventions
Drug: Ethynil Estradiol/Norgestimate Oral Contraceptive
First Posted Date
2016-06-07
Last Posted Date
2018-12-20
Lead Sponsor
Amgen
Target Recruit Count
41
Registration Number
NCT02792517
Locations
🇺🇸

Research Site, Madison, Wisconsin, United States

Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2016-04-18
Last Posted Date
2019-04-02
Lead Sponsor
Amgen
Target Recruit Count
34
Registration Number
NCT02741310
Locations
🇧🇪

Research Site, Leuven, Belgium

A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention

Phase 2
Completed
Conditions
Migraine
Interventions
Drug: Placebo
First Posted Date
2015-12-15
Last Posted Date
2022-10-12
Lead Sponsor
Amgen
Target Recruit Count
475
Registration Number
NCT02630459
Locations
🇯🇵

Research Site, Kai-shi, Yamanashi, Japan

Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Phase 2
Completed
Conditions
Stable Angina
Interventions
Drug: Placebo
First Posted Date
2015-10-15
Last Posted Date
2018-08-24
Lead Sponsor
Amgen
Target Recruit Count
89
Registration Number
NCT02575833
Locations
🇨🇭

Research Site, Geneva 14, Switzerland

To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients

Phase 1
Completed
Conditions
Migraine
Interventions
Drug: PACAP-38 Challenge Agent
Drug: Placebo
First Posted Date
2015-09-07
Last Posted Date
2019-06-03
Lead Sponsor
Amgen
Target Recruit Count
35
Registration Number
NCT02542605
Locations
🇳🇱

Research Site, Leiden, Netherlands

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention

Phase 3
Completed
Conditions
Migraine
Interventions
Drug: Placebo
First Posted Date
2015-06-29
Last Posted Date
2022-10-12
Lead Sponsor
Amgen
Target Recruit Count
577
Registration Number
NCT02483585
Locations
🇨🇭

Research Site, Zollikon, Switzerland

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention

Phase 3
Completed
Conditions
Migraine
Interventions
Drug: Placebo
First Posted Date
2015-05-28
Last Posted Date
2022-10-12
Lead Sponsor
Amgen
Target Recruit Count
955
Registration Number
NCT02456740
Locations
🇬🇧

Research Site, Stoke on Trent, United Kingdom

A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.

Phase 2
Completed
Conditions
Treatment for Prevention of Chronic Migraine
Interventions
First Posted Date
2014-06-26
Last Posted Date
2022-10-12
Lead Sponsor
Amgen
Target Recruit Count
609
Registration Number
NCT02174861
Locations
🇬🇧

Research Site, Stoke on Trent, United Kingdom

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