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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00820105
Other study ID # ADX10059-206
Secondary ID 2008-005481-30
Status Terminated
Phase Phase 2
First received January 8, 2009
Last updated December 23, 2009
Start date December 2008

Study information

Verified date December 2009
Source Addex Pharma S.A.
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

Evaluation of ADX10059 to prevent migraine attacks


Recruitment information / eligibility

Status Terminated
Enrollment 350
Est. completion date
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
ADX10059
oral administration
ADX10059
Oral administration
ADX10059
Oral administration
ADX10059 Matching Placebo
Oral administration

Locations

Country Name City State
Belgium Liège Liège
Belgium Sint-Truiden Sint-Truiden
Belgium Wilrijk Wilrijk
France Lille Lille
France Nice Nice
France Paris Paris
France Toulouse Toulouse
Germany 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
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
United Kingdom Berkshire Berkshire
United Kingdom Cardiff Cardiff
United Kingdom Liverpool Liverpool
United Kingdom 24 London
United Kingdom Manchester Manchester

Sponsors (1)

Lead Sponsor Collaborator
Addex Pharma S.A.

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of migraine headache days during weeks 9-12 of the treatment period 12 weeks No
Secondary Migraine frequency 12 weeks No
Secondary Migraine severity 12 weeks No
Secondary Migraine duration 12 weeks No
Secondary Occurrence of aura 12 weeks No
Secondary Functional impairment severity 12 weeks No
Secondary Rescue medication use 12 weeks No
Secondary Proportion of responders 12 weeks No
Secondary Global assessment of study medication 12 weeks No
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