A Phase 1 interventional study of Eslicarbazepine acetate and Oxcarbazepine in Partial Epilepsy, sponsored by Bial - Portela C S.A.. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-19.
Sponsored by Bial - Portela C S.A. · Phase 1, Interventional, and Treatment
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 14 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Bial - Portela C S.A. is the lead sponsor of 133 studies on the registry; 1 is open to participants now.
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Inclusion Criteria:
Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9
Drug: Eslicarbazepine acetate
Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
Drug: Oxcarbazepine
Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9
Also known as: BIA 2-093
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)
Also known as: Trileptal, Trexapin, 10,11-Dihydro-10-oxo-5 H -dibenz(b,f)azepine-5-carboxamide
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.
Time frame: 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.
Time frame: Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h
| Milestone | Eslicarbazepine Acetate | Oxcarbazepine |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
Cmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.
| ng/mL | Eslicarbazepine Acetate | Oxcarbazepine |
|---|---|---|
| Cmax (BIA 2-194) plasma | 23932 ± 6630 | 16162 ± 2662 |
| Cmax (BIA 2-195) plasma | 886 ± 235 | 4039 ± 613 |
| Cmax (Oxcarbazepine) plasma | 245 ± 72.6 | 1990 ± 941 |
| Cmax (BIA 2-194) CSF | 7559 ± 1050 | 7566 ± 912 |
| Cmax (BIA 2-195) CSF | 538 ± 145 | 2146 ± 327 |
| Cmax (Oxcarbazepine) CSF | 93.2 ± 27.0 | 448 ± 109 |
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.
| ng.h/mL | Eslicarbazepine Acetate | Oxcarbazepine |
|---|---|---|
| AUC0-t (BIA 2-194) plasma | 340123 ± 70412 | 164726 ± 29904 |
| AUC0-t (BIA 2-195) plasma | 18743 ± 4620 | 39034 ± 7094 |
| AUC0-t (Oxcarbazepine) plasma | 3377 ± 762 | 7135 ± 2561 |
| AUC0-t (BIA 2-194) CSF | 154509 ± 22495 | 86187 ± 9545 |
| AUC0-t (BIA 2-195) CSF | 11791 ± 2909 | 23996 ± 3495 |
| AUC0-t (Oxcarbazepine) CSF | 1522 ± 287 | 2485 ± 400 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eslicarbazepine Acetate | — | 0/7 (0%) | 6/7 (85.7%) |
| Oxcarbazepine | — | 0/7 (0%) | 7/7 (100%) |
| Event | Eslicarbazepine Acetate | Oxcarbazepine |
|---|---|---|
| HeadacheNervous system disorders | 2/7 | 7/7 |
| DizzinessNervous system disorders | 3/7 | 6/7 |
| NauseaGastrointestinal disorders | 1/7 | 5/7 |
| Back painMusculoskeletal and connective tissue disorders | 1/7 | 5/7 |
| FatigueGeneral disorders | 2/7 | 5/7 |
| SomnolenceNervous system disorders | 1/7 | 3/7 |
| Stomach discomfortGastrointestinal disorders | 0/7 | 3/7 |
| Vision blurredEye disorders | 0/7 | 3/7 |
| SyncopeNervous system disorders | 2/7 | 1/7 |
| Memory impairmentNervous system disorders | 0/7 | 2/7 |
| Age, Categorical(Participants) | Eslicarbazepine Acetate | Oxcarbazepine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 7 | 14 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Eslicarbazepine Acetate | Oxcarbazepine | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 4 | 3 | 7 |
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Bial - Portela C S.A.