Trial Outcomes & Findings for Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine (NCT NCT00900237)
NCT ID: NCT00900237
Last Updated: 2014-12-19
Results Overview
Cmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h
Results posted on
2014-12-19
Participant Flow
Participant milestones
| Measure |
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
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine
Baseline characteristics by cohort
| Measure |
Eslicarbazepine Acetate
n=7 Participants
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
|
Oxcarbazepine
n=7 Participants
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)
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24hCmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.
Outcome measures
| Measure |
Eslicarbazepine Acetate
n=7 Participants
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
|
Oxcarbazepine
n=7 Participants
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)
|
|---|---|---|
|
Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid
Cmax (BIA 2-194) plasma
|
23932 ng/mL
Standard Deviation 6630
|
16162 ng/mL
Standard Deviation 2662
|
|
Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid
Cmax (BIA 2-195) plasma
|
886 ng/mL
Standard Deviation 235
|
4039 ng/mL
Standard Deviation 613
|
|
Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid
Cmax (Oxcarbazepine) plasma
|
245 ng/mL
Standard Deviation 72.6
|
1990 ng/mL
Standard Deviation 941
|
|
Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid
Cmax (BIA 2-194) CSF
|
7559 ng/mL
Standard Deviation 1050
|
7566 ng/mL
Standard Deviation 912
|
|
Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid
Cmax (BIA 2-195) CSF
|
538 ng/mL
Standard Deviation 145
|
2146 ng/mL
Standard Deviation 327
|
|
Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid
Cmax (Oxcarbazepine) CSF
|
93.2 ng/mL
Standard Deviation 27.0
|
448 ng/mL
Standard Deviation 109
|
PRIMARY outcome
Timeframe: Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24hAUC0-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.
Outcome measures
| Measure |
Eslicarbazepine Acetate
n=7 Participants
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
|
Oxcarbazepine
n=7 Participants
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)
|
|---|---|---|
|
AUC0-t AUC From Time Zero to the Last Sampling Time
AUC0-t (BIA 2-194) plasma
|
340123 ng.h/mL
Standard Deviation 70412
|
164726 ng.h/mL
Standard Deviation 29904
|
|
AUC0-t AUC From Time Zero to the Last Sampling Time
AUC0-t (BIA 2-195) plasma
|
18743 ng.h/mL
Standard Deviation 4620
|
39034 ng.h/mL
Standard Deviation 7094
|
|
AUC0-t AUC From Time Zero to the Last Sampling Time
AUC0-t (Oxcarbazepine) plasma
|
3377 ng.h/mL
Standard Deviation 762
|
7135 ng.h/mL
Standard Deviation 2561
|
|
AUC0-t AUC From Time Zero to the Last Sampling Time
AUC0-t (BIA 2-194) CSF
|
154509 ng.h/mL
Standard Deviation 22495
|
86187 ng.h/mL
Standard Deviation 9545
|
|
AUC0-t AUC From Time Zero to the Last Sampling Time
AUC0-t (BIA 2-195) CSF
|
11791 ng.h/mL
Standard Deviation 2909
|
23996 ng.h/mL
Standard Deviation 3495
|
|
AUC0-t AUC From Time Zero to the Last Sampling Time
AUC0-t (Oxcarbazepine) CSF
|
1522 ng.h/mL
Standard Deviation 287
|
2485 ng.h/mL
Standard Deviation 400
|
Adverse Events
Eslicarbazepine Acetate
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Oxcarbazepine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eslicarbazepine Acetate
n=7 participants at risk
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
|
Oxcarbazepine
n=7 participants at risk
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)
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
42.9%
3/7
|
85.7%
6/7
|
|
Nervous system disorders
Headache
|
28.6%
2/7
|
100.0%
7/7
|
|
Nervous system disorders
Somnolence
|
14.3%
1/7
|
42.9%
3/7
|
|
Nervous system disorders
Syncope
|
28.6%
2/7
|
14.3%
1/7
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/7
|
28.6%
2/7
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7
|
71.4%
5/7
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/7
|
42.9%
3/7
|
|
Gastrointestinal disorders
Hypoesthesia oral
|
14.3%
1/7
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7
|
71.4%
5/7
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
28.6%
2/7
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
14.3%
1/7
|
14.3%
1/7
|
|
General disorders
Fatigue
|
28.6%
2/7
|
71.4%
5/7
|
|
Eye disorders
Vision blurred
|
0.00%
0/7
|
42.9%
3/7
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7
|
28.6%
2/7
|
|
Injury, poisoning and procedural complications
Postlumbar puncture syndrome
|
14.3%
1/7
|
0.00%
0/7
|
Additional Information
Head of Clinical Research
Bial - Portela & Cª, S.A.
Phone: +351 229 866 100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER