ADX10059 Migraine Prevention Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00820105
• Date of registration: 08/01/2009
• Prospective Registration: No
• Primary sponsor: Addex Pharma S.A.
• Public title: ADX10059 Migraine Prevention Study
• Scientific title: 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
• Date of first enrolment: December 2008
• Target sample size: 350
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00820105
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, France, Germany, United Kingdom

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Migraine

Intervention(s)

Drug: ADX10059

Drug: ADX10059 Matching Placebo

Primary Outcome(s)

Number of migraine headache days during weeks 9-12 of the treatment period [Time Frame: 12 weeks]

Secondary Outcome(s)

Migraine frequency [Time Frame: 12 weeks]

Global assessment of study medication [Time Frame: 12 weeks]

Migraine severity [Time Frame: 12 weeks]

Functional impairment severity [Time Frame: 12 weeks]

Occurrence of aura [Time Frame: 12 weeks]

Migraine duration [Time Frame: 12 weeks]

Proportion of responders [Time Frame: 12 weeks]

Rescue medication use [Time Frame: 12 weeks]

Secondary ID(s)

2008-005481-30

ADX10059-206

Source(s) of Monetary Support

Please refer to primary and secondary sponsors