ADX10059 Migraine Prevention Study

Addex Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Migraine

Treatments: Drug: ADX10059; Drug: ADX10059 Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00820105

2008-005481-30

ADX10059-206

Details and patient eligibility

About

Evaluation of ADX10059 to prevent migraine attacks

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 4 patient groups, including a placebo group

ADX10059 25 mg

Experimental group

Description:

Weeks 1-2: once daily Weeks 3-12: twice daily

Treatment:

Drug: ADX10059

Drug: ADX10059

Drug: ADX10059

ADX10059 50 mg

Experimental group

Description:

Weeks 1-2: once daily Weeks 3-12: twice daily

Treatment:

Drug: ADX10059

Drug: ADX10059

Drug: ADX10059

ADX10059 100 mg

Experimental group

Description:

Weeks 1-2: once daily Weeks 3-12: twice daily

Treatment:

Drug: ADX10059

Drug: ADX10059

Drug: ADX10059

ADX10059 Matching Placebo

Placebo Comparator group

Description:

Weeks 1-2: once daily Weeks 3-12: twice daily

Treatment:

Drug: ADX10059 Matching Placebo