ADX10059 Migraine Prevention Study

Phase 2

Terminated

• Conditions: Migraine
• Interventions: Drug: ADX10059; Drug: ADX10059 Matching Placebo

• Registration Number: NCT00820105
• Lead Sponsor: Addex Pharma S.A.

Brief Summary

Evaluation of ADX10059 to prevent migraine attacks

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-23
• Last Update Posted: 2009-12-24
• Primary Completion: 2010-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADX10059 25 mg	ADX10059	Weeks 1-2: once daily Weeks 3-12: twice daily
ADX10059 50 mg	ADX10059	Weeks 1-2: once daily Weeks 3-12: twice daily
ADX10059 100 mg	ADX10059	Weeks 1-2: once daily Weeks 3-12: twice daily
ADX10059 Matching Placebo	ADX10059 Matching Placebo	Weeks 1-2: once daily Weeks 3-12: twice daily

Primary Outcome Measures

Name	Time	Method
Number of migraine headache days during weeks 9-12 of the treatment period	12 weeks

Secondary Outcome Measures

Name	Time	Method
Migraine frequency	12 weeks
Migraine severity	12 weeks
Migraine duration	12 weeks
Occurrence of aura	12 weeks
Functional impairment severity	12 weeks
Rescue medication use	12 weeks
Proportion of responders	12 weeks
Global assessment of study medication	12 weeks

Trial Locations

Locations (30)

Nice; 🇫🇷 Nice, France

Bochum; 🇩🇪 Bochum, Germany

Leipzig; 🇩🇪 Leipzig, Germany

Berlin Hellersdorf 11; 🇩🇪 Berlin, Germany

Cardiff; 🇬🇧 Cardiff, United Kingdom

24; 🇬🇧 London, United Kingdom

Lille; 🇫🇷 Lille, France

Liège; 🇧🇪 Liège, Belgium

Paris; 🇫🇷 Paris, France

Manchester; 🇬🇧 Manchester, United Kingdom

Hamburg; 🇩🇪 Hamburg, Germany

Liverpool; 🇬🇧 Liverpool, United Kingdom

Frankfurt; 🇩🇪 Frankfurt, Germany

Sint-Truiden; 🇧🇪 Sint-Truiden, Belgium

Wilrijk; 🇧🇪 Wilrijk, Belgium

06; 🇩🇪 Berlin, Germany

Toulouse; 🇫🇷 Toulouse, France

Dreseden; 🇩🇪 Dresden, Germany

28; 🇩🇪 Essen, Germany

02; 🇩🇪 Essen, Germany

Freiburg; 🇩🇪 Freiburg, Germany

Göppingen; 🇩🇪 Göppingen, Germany

Görlitz; 🇩🇪 Görlitz, Germany

Itzehoe; 🇩🇪 Itzehoe, Germany

05; 🇩🇪 München, Germany

10; 🇩🇪 München, Germany

Münster; 🇩🇪 Münster, Germany

Magdeburg; 🇩🇪 Magdeburg, Germany

Wiesbaden; 🇩🇪 Wiesbaden, Germany

Berkshire; 🇬🇧 Berkshire, United Kingdom