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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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The purpose of the study is to examine the clinical safety, tolerability, and efficacy of clobazam (Onfi) when it replaces the pre-existing clonazepam therapy in patients with refractory epilepsy.
The study is designed to answer frequently asked questions when clinicians replace existing 1,4-benzodiazepine to Onfi, as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clonazepam conversion to clobazam (Onfi) | Experimental | Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clobazam (Onfi) | Drug | Subject's clonazepam will be converted to the following Onfi doses per day: Clonazepam 0.5mg converted to Onfi 10mg first week, then titrated up to 40mg per day. Clonazepam 1.0-2.0mg converted to Onfi 20mg first week, then titrated up to 40mg per day. Clonazepam 2-4mg converted to Onfi 20mg first week, then titrated up to 60mg per day. Initial conversion will occur over two weeks followed by upward titration of up to 10mg increment per week toward the target dose. Down titration of up to 10mg will be allowed during the study. The following will be the initial conversion schedule from clonazepam to Onfi: Week 1: 50% reduction of clonazepam and starting dose of Onfi, replacing the reduced clonazepam dose with the conversion rate of clonazepam 0.5mg = Onfi 10mg. Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold. Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Efficacy will be measured by percentage of mean seizure reduction averaged over 28 days. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability | Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 6 weeks, 12 weeks, 24 weeks, and 52 weeks. | Weeks 6 - 52 after medication conversion |
| Retention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Chung, MD | Banner Health Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Health | Phoenix | Arizona | 85006 | United States |
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| Initial conversion and titration | Drug | Initial conversion will occur over two weeks followed by upward titration of up to 10mg increment per week toward the target dose. Down titration of up to 10mg will be allowed during the study. |
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| Conversion schedule - Week 1 | Drug | The following will be the initial conversion schedule from clonazepam to Onfi: Week 1: 50% reduction of clonazepam and starting dose of Onfi, replacing the reduced clonazepam dose with the conversion rate of clonazepam 0.5mg=Onfi 10mg. |
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| Conversion schedule - Week 2 | Drug | Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold. |
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| Conversion schedule - Week 3 | Drug | Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated. |
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Retention rate of Onfi at 6-months and 12-months.
| 52 weeks |
| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078306 | Clobazam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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