Migraine
Conditions
Keywords
Migraine, Aura, Migraine headache
Brief summary
Evaluation of ADX10059 to prevent migraine attacks
Interventions
DRUGADX10059
oral administration
Oral administration
Sponsors
Addex Pharma S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of migraine headache days during weeks 9-12 of the treatment period | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of responders | 12 weeks |
| Global assessment of study medication | 12 weeks |
| Migraine frequency | 12 weeks |
| Rescue medication use | 12 weeks |
| Migraine duration | 12 weeks |
| Occurrence of aura | 12 weeks |
| Functional impairment severity | 12 weeks |
| Migraine severity | 12 weeks |
Countries
Austria, Belgium, France, Germany, United Kingdom
Outcome results
None listed