ADX10059 Migraine Prevention Study

Migraine Clinical Trial

Official title:

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

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. 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

• Migraine
• Migraine Disorders

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