Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
350 participants
INTERVENTIONAL
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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ADX10059 25 mg
Weeks 1-2: once daily Weeks 3-12: twice daily
ADX10059
oral administration
ADX10059 50 mg
Weeks 1-2: once daily Weeks 3-12: twice daily
ADX10059
Oral administration
ADX10059 100 mg
Weeks 1-2: once daily Weeks 3-12: twice daily
ADX10059
Oral administration
ADX10059 Matching Placebo
Weeks 1-2: once daily Weeks 3-12: twice daily
ADX10059 Matching Placebo
Oral administration
Interventions
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ADX10059
oral administration
ADX10059
Oral administration
ADX10059
Oral administration
ADX10059 Matching Placebo
Oral administration
Eligibility Criteria
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Inclusion Criteria
* History of migraine
* Aged ≤ 50 years at onset of migraine history
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Addex Pharma S.A.
INDUSTRY
Responsible Party
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Addex Pharma SA
Locations
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Vienna, , Austria
Liège
Liège, , Belgium
Sint-Truiden
Sint-Truiden, , Belgium
Wilrijk
Wilrijk, , Belgium
Lille
Lille, , France
Nice
Nice, , France
Paris
Paris, , France
Toulouse
Toulouse, , France
06
Berlin, , Germany
Berlin Hellersdorf 11
Berlin, , Germany
Bochum
Bochum, , Germany
Dreseden
Dresden, , Germany
02
Essen, , Germany
28
Essen, , Germany
Frankfurt
Frankfurt, , Germany
Freiburg
Freiburg im Breisgau, , Germany
Göppingen
Göppingen, , Germany
Görlitz
Görlitz, , Germany
Hamburg
Hamburg, , Germany
Itzehoe
Itzehoe, , Germany
Leipzig
Leipzig, , Germany
Magdeburg
Magdeburg, , Germany
05
München, , Germany
10
München, , Germany
Münster
Münster, , Germany
Wiesbaden
Wiesbaden, , Germany
Berkshire
Berkshire, , United Kingdom
Cardiff
Cardiff, , United Kingdom
Liverpool
Liverpool, , United Kingdom
24
London, , United Kingdom
Manchester
Manchester, , United Kingdom
Countries
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Other Identifiers
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2008-005481-30
Identifier Type: -
Identifier Source: secondary_id
ADX10059-206
Identifier Type: -
Identifier Source: org_study_id