Trial | NCT00820105  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    adx10059 ...

  • Study Participants

    350
Evaluation of ADX10059 to prevent migraine attacks
Study Started
Dec 31
2008
Primary Completion
Jan 31
2010
Anticipated
Last Update
Dec 24
2009
Estimate

Drug ADX10059

oral administration

Drug ADX10059

Oral administration

Drug ADX10059

Oral administration

Drug ADX10059 Matching Placebo

Oral administration

ADX10059 25 mg Experimental

Weeks 1-2: once daily Weeks 3-12: twice daily

ADX10059 50 mg Experimental

Weeks 1-2: once daily Weeks 3-12: twice daily

ADX10059 100 mg Experimental

Weeks 1-2: once daily Weeks 3-12: twice daily

ADX10059 Matching Placebo Placebo Comparator

Weeks 1-2: once daily Weeks 3-12: twice daily

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
No Results Posted