ADX10059 Migraine Prevention Study

A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multicentre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 for the Prevention of Migraine

Evaluation of ADX10059 to prevent migraine attacks

Inclusion Criteria:

• Male and female patients aged 18 to 65 years
• History of migraine
• Aged ≤ 50 years at onset of migraine history

Exclusion Criteria:

• Cluster headache or chronic migraine headaches
• Currently uses, or within 3 months of Screening, has used: sodium valproate or topiramate and any other drugs used specifically for migraine prophylaxis, for example beta-blockers, calcium channel blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors
• Unable to distinguish migraine headache from tension and other types of headache
• Current history of psychiatric disorder requiring regular medication
• Known history of alcohol abuse
• Known clinically significant allergy or known hypersensitivity to drugs
• History of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study
• Pregnant or breast-feeding