ALD403 for Chronic Migraine Prevention

• Research type

  Research Study

• Full title

  A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients with Chronic Migraine

• IRAS ID

  216496

• Contact name

  Jennifer Wiley

• Contact email

  jwiley@alderbio.com

• Sponsor organisation

  Alder BioPharmaceuticals, Inc.

• Eudract number

  2016-001306-41

• Duration of Study in the UK

  1 years, 2 months, 14 days

• Research summary

  Migraine is the most prevalent neurological disease for which medical treatment is sought and considered the 6th leading cause of disability in the world. Numerous medications are used to prevent migraine but to date none have been designed
  specifically for migraine. These commonly include tricyclic antidepressants, beta-blockers, and certain anticonvulsants. It is estimated that 45% of adults with frequent episodic migraine and virtually all with chronic migraine would benefit from effective preventive medications yet only an estimated 12% of this population are currently using a migraine preventive. This is generally due to poor tolerability, lack of efficacy, and failure to adhere to treatment.

  Calcitonin gene-related peptide (CGRP) is produced in both peripheral and central neurons and is involved in pain transmission associated with migraine. In addition, many pharmacological agents used as acute or prophylactic treatment of migraine are known to inhibit CGRP. ALD403 is a genetically engineered humanized immunoglobulin G1 (IgG1) antibody that binds to CGRP.

  The proposed double-blind study will assess the safety and effectiveness of ALD403 administered intravenously in participants with chronic migraine, compared to placebo. 1050 participants will take part in this study in the UK, other EU countries and the USA. Each participant will be in the study for approximately 36 weeks, comprising of a screening period, followed by 10 study visits, if the participant is found to be eligible. Procedures involved include physical examinations, ECGs, blood samples, completion of a headache eDiary and completion of questionnaires. This study is sponsored by Alder BioPharmaceuticals Inc.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  17/EM/0006

• Date of REC Opinion

  10 Feb 2017

• REC opinion

  Further Information Favourable Opinion