ADX10059 Migraine Prevention Study

Study Overview
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Brief Summary
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Evaluation of ADX10059 to prevent migraine attacks

Official Title
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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

Conditions
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Migraine

Intervention / Treatment
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* Drug: ADX10059
* Drug: ADX10059
* Drug: ADX10059
* Drug: ADX10059 Matching Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADX10059 25 mg<br>Weeks 1-2: once daily Weeks 3-12: twice daily | Drug: ADX10059<br>* oral administration<br>|
| Experimental: ADX10059 50 mg<br>Weeks 1-2: once daily Weeks 3-12: twice daily | Drug: ADX10059<br>* Oral administration<br>|
| Experimental: ADX10059 100 mg<br>Weeks 1-2: once daily Weeks 3-12: twice daily | Drug: ADX10059<br>* Oral administration<br>|
| Placebo Comparator: ADX10059 Matching Placebo<br>Weeks 1-2: once daily Weeks 3-12: twice daily | Drug: ADX10059 Matching Placebo<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of migraine headache days during weeks 9-12 of the treatment period |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Aura, Migraine headache