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This purpose of this study is to measure the concentrations of two anti-epileptic drugs (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blood plasma of healthy subjects and also to assess how these drugs are tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eslicarbazepine acetate | Active Comparator | Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9 |
|
| Oxcarbazepine | Active Comparator | Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eslicarbazepine acetate | Drug | Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid | Cmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate. | Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h |
| AUC0-t AUC From Time Zero to the Last Sampling Time | AUC0-t - area under the concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification CSF - cerebrospinal fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate. | Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luc Cavens, MD | SGS LSS Clinical Pharmacology Unit Antwerpen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS LSS Clinical Pharmacology Unit Antwerpen | Antwerp | B-2060 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eslicarbazepine Acetate | Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9 Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9 |
| FG001 | Oxcarbazepine | Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9 Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eslicarbazepine Acetate | Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9 Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9 |
| BG001 | Oxcarbazepine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid | Cmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate. | Posted | Mean | Standard Deviation | ng/mL | Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eslicarbazepine Acetate | Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9 Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (11.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Research | Bial - Portela & Cª, S.A. | +351 229 866 100 | jose.rocha@bial.com |
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| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C416835 | eslicarbazepine acetate |
| D000078330 | Oxcarbazepine |
| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Oxcarbazepine | Drug | Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9) |
|
|
Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9 Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | AUC0-t AUC From Time Zero to the Last Sampling Time | AUC0-t - area under the concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification CSF - cerebrospinal fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate. | Posted | Mean | Standard Deviation | ng.h/mL | Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h |
|
|
|
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | Oxcarbazepine | Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9 Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9) | 0 | 7 | 7 | 7 |
| Headache | Nervous system disorders | MedDRA (11.1) |
|
| Somnolence | Nervous system disorders | MedDRA (11.1) |
|
| Syncope | Nervous system disorders | MedDRA (11.1) |
|
| Memory impairment | Nervous system disorders | MedDRA (11.1) |
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| Nausea | Gastrointestinal disorders | MedDRA (11.1) |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA (11.1) |
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| Hypoesthesia oral | Gastrointestinal disorders | MedDRA (11.1) |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
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| Fatigue | General disorders | MedDRA (11.1) |
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| Vision blurred | Eye disorders | MedDRA (11.1) |
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| Nasopharyngitis | Infections and infestations | MedDRA (11.1) |
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| Postlumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA (11.1) |
|
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| D006571 | Heterocyclic Compounds |
| AUC0-t (Oxcarbazepine) plasma |
|
| AUC0-t (BIA 2-194) CSF |
|
| AUC0-t (BIA 2-195) CSF |
|
| AUC0-t (Oxcarbazepine) CSF |
|