Trial Outcomes & Findings for A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093 (NCT NCT02171234)

NCT ID: NCT02171234

Last Updated: 2015-01-07

Results Overview

Total Number of Adverse Events.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

up to 20 weeks

Results posted on

2015-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo PLC, Placebo	Group 1 - 200 mg b.i.d. BIA 2-093 200mg (twice daily)	Group 2 - 400 mg o.d. BIA 2-093, ESL, Eslicarbazepine 400mg	Group 3 - 800 mg o.d. BIA 2-093, ESL, Eslicarbazepine 800mg	Group 4 - 1200 mg o.d. BIA 2-093, ESL, Eslicarbazepine 1200mg
Overall Study STARTED	8	6	6	6	6
Overall Study COMPLETED	8	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=8 Participants PLC, Placebo	Group 1 - BIA 2-093 200 mg b.i.d. n=6 Participants BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)	Group 2 - BIA 2-093 400 mg o.d. n=6 Participants BIA 2-093, ESL, Eslicarbazepine acetate 400mg	Group 3 - BIA 2-093 800 mg o.d. n=6 Participants BIA 2-093, ESL, Eslicarbazepine acetate 800mg	Group 4 - BIA 2-093 1200 mg o.d. n=6 Participants BIA 2-093, ESL, Eslicarbazepine acetate 1200mg	Total n=32 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	32 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	32 Participants n=10 Participants

PRIMARY outcome

Timeframe: up to 20 weeks

Total Number of Adverse Events.

Outcome measures

Outcome measures
Measure	Group 1 - BIA 2-093 200 mg b.i.d. n=6 Participants BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)	Group 2 - BIA 2-093 400 mg o.d. n=6 Participants BIA 2-093, ESL, Eslicarbazepine acetate 400mg	Group 3 - BIA 2-093 800 mg o.d. n=6 Participants BIA 2-093, ESL, Eslicarbazepine acetate 800mg	Group 4 - BIA 2-093 1200 mg o.d. n=6 Participants BIA 2-093, ESL, Eslicarbazepine acetate 1200mg	Placebo n=8 Participants PLC, Placebo
Total Number of Adverse Events Adverse Events of Moderate Severity	0 Total Number of AE	0 Total Number of AE	1 Total Number of AE	0 Total Number of AE	0 Total Number of AE
Total Number of Adverse Events All Adverse Events	9 Total Number of AE	15 Total Number of AE	5 Total Number of AE	12 Total Number of AE	14 Total Number of AE
Total Number of Adverse Events AE Considered Not Related to Treatment	3 Total Number of AE	2 Total Number of AE	0 Total Number of AE	0 Total Number of AE	1 Total Number of AE
Total Number of Adverse Events AE Considered Possibly Related to Treatment	6 Total Number of AE	13 Total Number of AE	5 Total Number of AE	12 Total Number of AE	13 Total Number of AE
Total Number of Adverse Events Adverse Events of Mild Severity	9 Total Number of AE	15 Total Number of AE	4 Total Number of AE	12 Total Number of AE	14 Total Number of AE

SECONDARY outcome

Timeframe: Day 1 and Day 8

Cmax - Maximum observed plasma concentration

Outcome measures

Outcome measures
Measure	Group 1 - BIA 2-093 200 mg b.i.d. n=6 Participants BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)	Group 2 - BIA 2-093 400 mg o.d. n=6 Participants BIA 2-093, ESL, Eslicarbazepine acetate 400mg	Group 3 - BIA 2-093 800 mg o.d. n=6 Participants BIA 2-093, ESL, Eslicarbazepine acetate 800mg	Group 4 - BIA 2-093 1200 mg o.d. n=6 Participants BIA 2-093, ESL, Eslicarbazepine acetate 1200mg	Placebo PLC, Placebo
Cmax Cmax Day 1	3086 ng/ml Standard Error 1342	7827 ng/ml Standard Error 1313	11074 ng/ml Standard Error 1919	16071 ng/ml Standard Error 2238	—
Cmax Cmax Day 8	6683 ng/ml Standard Error 1576	8824 ng/ml Standard Error 1411	18675 ng/ml Standard Error 2613	25457 ng/ml Standard Error 2746	—

SECONDARY outcome

Timeframe: Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose

AUC0-τ - Area under the plasma concentration time curve to last measurable time point Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose