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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005481-30 |
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Incidence of abnormalities of liver function tests is higher than expected in this population.
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Evaluation of ADX10059 to prevent migraine attacks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADX10059 25 mg | Experimental | Weeks 1-2: once daily Weeks 3-12: twice daily |
|
| ADX10059 50 mg | Experimental | Weeks 1-2: once daily Weeks 3-12: twice daily |
|
| ADX10059 100 mg | Experimental | Weeks 1-2: once daily Weeks 3-12: twice daily |
|
| ADX10059 Matching Placebo | Placebo Comparator | Weeks 1-2: once daily Weeks 3-12: twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX10059 | Drug | oral administration |
| |
| ADX10059 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of migraine headache days during weeks 9-12 of the treatment period | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine frequency | 12 weeks | |
| Migraine severity | 12 weeks | |
| Migraine duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | Austria | |||||
| Liège |
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| Drug |
Oral administration |
|
| ADX10059 | Drug | Oral administration |
|
| ADX10059 Matching Placebo | Drug | Oral administration |
|
| 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 |
| Liège |
| Belgium |
| Sint-Truiden | Sint-Truiden | Belgium |
| Wilrijk | Wilrijk | Belgium |
| Lille | Lille | France |
| Nice | Nice | France |
| Paris | Paris | France |
| Toulouse | Toulouse | France |
| 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 im Breisgau | 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 | Germany |
| Berkshire | Berkshire | United Kingdom |
| Cardiff | Cardiff | United Kingdom |
| Liverpool | Liverpool | United Kingdom |
| 24 | London | United Kingdom |
| Manchester | Manchester | United Kingdom |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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