ADX10059 Migraine Prevention Study - Full Text View

Sponsor:	Addex Pharma S.A.
Information provided by:	Addex Pharma S.A.
ClinicalTrials.gov Identifier:	NCT00820105

Purpose

Evaluation of ADX10059 to prevent migraine attacks

Condition	Intervention	Phase
Migraine	Drug: ADX10059 Drug: ADX10059 Matching Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by Addex Pharma S.A.:

Primary Outcome Measures:

Number of migraine headache days during weeks 9-12 of the treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Migraine frequency [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Migraine severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Migraine duration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Occurrence of aura [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Functional impairment severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Rescue medication use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Proportion of responders [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Global assessment of study medication [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	December 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ADX10059 25 mg Weeks 1-2: once daily Weeks 3-12: twice daily	Drug: ADX10059 oral administration
Experimental: ADX10059 50 mg Weeks 1-2: once daily Weeks 3-12: twice daily	Drug: ADX10059 Oral administration
Experimental: ADX10059 100 mg Weeks 1-2: once daily Weeks 3-12: twice daily	Drug: ADX10059 Oral administration
Placebo Comparator: ADX10059 Matching Placebo Weeks 1-2: once daily Weeks 3-12: twice daily	Drug: ADX10059 Matching Placebo Oral administration

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820105

Locations

Sponsors and Collaborators

Addex Pharma S.A.

More Information

No publications provided

Responsible Party:	Study Director, Addex Pharma SA
ClinicalTrials.gov Identifier:	NCT00820105 History of Changes
Other Study ID Numbers:	ADX10059-206, 2008-005481-30
Study First Received:	January 8, 2009
Last Updated:	December 23, 2009
Health Authority:	Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Addex Pharma S.A.:

Migraine
Aura
Migraine headache

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 24, 2012