Trial Outcomes & Findings for A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate (NCT NCT02283814)
NCT ID: NCT02283814
Last Updated: 2025-04-11
Results Overview
BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
Results posted on
2025-04-11
Participant Flow
Participant milestones
| Measure |
Group A BIA 2-093 + Topamax
Group A
* Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;
* Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days
* Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days
BIA 2-093
Topamax
|
Group B BIA 2-093 + Topamax
* Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;
* Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;
* Treatment: 200 mg once daily dose of TPM administered for four consecutive days;
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days
BIA 2-093
Topamax
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate
Baseline characteristics by cohort
| Measure |
Group A BIA 2-093 + Topamax
n=13 Participants
Group A
* Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;
* Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days
* Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days
BIA 2-093
Topamax
|
Group B BIA 2-093 + Topamax
n=14 Participants
* Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;
* Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;
* Treatment: 200 mg once daily dose of TPM administered for four consecutive days;
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days
BIA 2-093
Topamax
|
Total
n=27 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
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24hBIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate
Outcome measures
| Measure |
BIA 2-093 + TPM
n=27 Participants
BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
|
BIA 2-093
n=16 Participants
BIA 2-093 - ESL; Eslicarbazepine acetate
|
|---|---|---|
|
Cmax - the Maximum Plasma Concentration
Cmax (BIA 2-194)
|
21960.6 ng/mL
Standard Deviation 2482
|
25414.8 ng/mL
Standard Deviation 3736
|
|
Cmax - the Maximum Plasma Concentration
Cmax (BIA 2-195)
|
931.8 ng/mL
Standard Deviation 216
|
1062.6 ng/mL
Standard Deviation 235
|
PRIMARY outcome
Timeframe: Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24hBIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate Both Groups A and B described in participant flow recieved BIA 2-093 and Topiramate. The results presented here are related with the different interventions in both groups
Outcome measures
| Measure |
BIA 2-093 + TPM
n=27 Participants
BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
|
BIA 2-093
n=16 Participants
BIA 2-093 - ESL; Eslicarbazepine acetate
|
|---|---|---|
|
Tmax - the Time of Occurrence of Cmax
Tmax (BIA 2-194)
|
2.00 hours
Standard Deviation 0.96
|
2.00 hours
Standard Deviation 0.97
|
|
Tmax - the Time of Occurrence of Cmax
Tmax (BIA 2-195)
|
9.00 hours
Standard Deviation 4.20
|
6.00 hours
Standard Deviation 3.91
|
SECONDARY outcome
Timeframe: Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24hBIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate
Outcome measures
| Measure |
BIA 2-093 + TPM
n=27 Participants
BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
|
BIA 2-093
n=16 Participants
BIA 2-093 - ESL; Eslicarbazepine acetate
|
|---|---|---|
|
AUCτ - Cumulative Area Under the Plasma Concentration Time Curve Over the Dosing Interval at Steady State.
AUCτ (BIA 2-194)
|
361733.9 ng*h/mL
Standard Deviation 38706
|
389794.3 ng*h/mL
Standard Deviation 35861
|
|
AUCτ - Cumulative Area Under the Plasma Concentration Time Curve Over the Dosing Interval at Steady State.
AUCτ (BIA 2-195)
|
19611.8 ng*h/mL
Standard Deviation 4707
|
22886.8 ng*h/mL
Standard Deviation 5195
|
Adverse Events
Group A BIA 2-093 + Topamax
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group B BIA 2-093 + Topamax
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A BIA 2-093 + Topamax
n=16 participants at risk
Group A
* Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;
* Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days
* Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days
BIA 2-093
Topamax
|
Group B BIA 2-093 + Topamax
n=16 participants at risk
* Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;
* Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;
* Treatment: 200 mg once daily dose of TPM administered for four consecutive days;
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days
BIA 2-093
Topamax
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
6.2%
1/16
|
0.00%
0/16
|
|
Eye disorders
dry eye
|
6.2%
1/16
|
6.2%
1/16
|
|
Eye disorders
Ocular hyperaemia
|
6.2%
1/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16
|
43.8%
7/16
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16
|
6.2%
1/16
|
|
Gastrointestinal disorders
Constipation
|
25.0%
4/16
|
12.5%
2/16
|
|
Gastrointestinal disorders
Diarrheoa
|
6.2%
1/16
|
12.5%
2/16
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
2/16
|
18.8%
3/16
|
|
Gastrointestinal disorders
hypoaesthesia teeth
|
6.2%
1/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Lip dry
|
31.2%
5/16
|
37.5%
6/16
|
|
Gastrointestinal disorders
Reflux gastritis
|
6.2%
1/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Tongue coated
|
6.2%
1/16
|
0.00%
0/16
|
|
General disorders
Fatigue
|
31.2%
5/16
|
37.5%
6/16
|
|
General disorders
Feeling drunk
|
12.5%
2/16
|
0.00%
0/16
|
|
General disorders
Feeling hot
|
12.5%
2/16
|
0.00%
0/16
|
|
General disorders
hot flush
|
18.8%
3/16
|
6.2%
1/16
|
|
General disorders
Pyrexia
|
6.2%
1/16
|
0.00%
0/16
|
|
General disorders
Venipuncture site redness
|
6.2%
1/16
|
0.00%
0/16
|
|
General disorders
Vessel puncture site bruise
|
12.5%
2/16
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Injury
|
6.2%
1/16
|
18.8%
3/16
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16
|
0.00%
0/16
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16
|
0.00%
0/16
|
|
Investigations
Red blood cells urine positive
|
6.2%
1/16
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
1/16
|
12.5%
2/16
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
6.2%
1/16
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
3/16
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
6.2%
1/16
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
1/16
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16
|
12.5%
2/16
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
6.2%
1/16
|
0.00%
0/16
|
|
Nervous system disorders
Coordination abnormal
|
6.2%
1/16
|
0.00%
0/16
|
|
Nervous system disorders
Disturbance in attention
|
25.0%
4/16
|
6.2%
1/16
|
|
Nervous system disorders
Dizziness
|
31.2%
5/16
|
6.2%
1/16
|
|
Nervous system disorders
Headache
|
43.8%
7/16
|
25.0%
4/16
|
|
Nervous system disorders
Somnolence
|
87.5%
14/16
|
81.2%
13/16
|
|
Nervous system disorders
Dysarthria
|
6.2%
1/16
|
0.00%
0/16
|
|
Nervous system disorders
Head discomfort
|
6.2%
1/16
|
0.00%
0/16
|
|
Nervous system disorders
Paraesthesia
|
6.2%
1/16
|
25.0%
4/16
|
|
Nervous system disorders
Paraesthesia oral
|
50.0%
8/16
|
18.8%
3/16
|
|
Nervous system disorders
Speech disorder
|
6.2%
1/16
|
0.00%
0/16
|
|
Nervous system disorders
Vision blurred
|
6.2%
1/16
|
25.0%
4/16
|
|
Psychiatric disorders
Erection increased
|
6.2%
1/16
|
6.2%
1/16
|
|
Psychiatric disorders
Euphoric mood
|
25.0%
4/16
|
18.8%
3/16
|
|
Psychiatric disorders
Irritability
|
6.2%
1/16
|
0.00%
0/16
|
|
Psychiatric disorders
Libido increased
|
6.2%
1/16
|
0.00%
0/16
|
|
Psychiatric disorders
Mood altered
|
12.5%
2/16
|
6.2%
1/16
|
|
Psychiatric disorders
Psychomotor retardation
|
12.5%
2/16
|
0.00%
0/16
|
|
Renal and urinary disorders
Dysuria
|
6.2%
1/16
|
0.00%
0/16
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
1/16
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16
|
12.5%
2/16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
1/16
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
12.5%
2/16
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Upper repiratory tract infection
|
6.2%
1/16
|
12.5%
2/16
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
6.2%
1/16
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16
|
12.5%
2/16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
2/16
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
6.2%
1/16
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
2/16
|
0.00%
0/16
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/16
|
6.2%
1/16
|
|
Eye disorders
Eye pain
|
0.00%
0/16
|
6.2%
1/16
|
|
Eye disorders
Photophobia
|
0.00%
0/16
|
12.5%
2/16
|
|
Eye disorders
Visual disturbance
|
0.00%
0/16
|
6.2%
1/16
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16
|
18.8%
3/16
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16
|
12.5%
2/16
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/16
|
6.2%
1/16
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16
|
18.8%
3/16
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/16
|
6.2%
1/16
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16
|
6.2%
1/16
|
|
Infections and infestations
Oral herpes
|
0.00%
0/16
|
6.2%
1/16
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/16
|
12.5%
2/16
|
|
Musculoskeletal and connective tissue disorders
Muscular discomfort
|
0.00%
0/16
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Muscular stiffness
|
0.00%
0/16
|
6.2%
1/16
|
|
Nervous system disorders
Amnesia
|
0.00%
0/16
|
6.2%
1/16
|
|
Nervous system disorders
Coordination decreased
|
0.00%
0/16
|
6.2%
1/16
|
|
Nervous system disorders
Insomnia
|
0.00%
0/16
|
6.2%
1/16
|
|
Nervous system disorders
Sensing disturbance
|
0.00%
0/16
|
6.2%
1/16
|
|
Psychiatric disorders
Agitation
|
0.00%
0/16
|
6.2%
1/16
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16
|
6.2%
1/16
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/16
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/16
|
6.2%
1/16
|
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