Trial Outcomes & Findings for A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures (NCT NCT03116828)
NCT ID: NCT03116828
Last Updated: 2020-06-16
Results Overview
Phase 4 study of eslicarbazepine acetate (ESL) as adjunctive therapy in adult subjects with a diagnosis of epilepsy with Partial-onset seizures (POS). Two groups of ESL-naïve subjects will be evaluated
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
102 participants
Primary outcome timeframe
From the date of the first dose of the study drug until the completion of 24 weeks Maintenance Phase
Results posted on
2020-06-16
Participant Flow
Participant milestones
| Measure |
Arm 1
(arm 1) Eslicarbazepine Acetate (ESL) as first add-on to Levetiracetam or Lamotrigine)
|
Arm 2
(arm 2) Eslicarbazepine Acetate (ESL) as later add-on to 1-2 Anti-epileptic drugs (AEDs)
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
58
|
|
Overall Study
COMPLETED
|
36
|
37
|
|
Overall Study
NOT COMPLETED
|
8
|
21
|
Reasons for withdrawal
| Measure |
Arm 1
(arm 1) Eslicarbazepine Acetate (ESL) as first add-on to Levetiracetam or Lamotrigine)
|
Arm 2
(arm 2) Eslicarbazepine Acetate (ESL) as later add-on to 1-2 Anti-epileptic drugs (AEDs)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
10
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
|
Overall Study
OTHER
|
3
|
3
|
Baseline Characteristics
for this outcome measure only 57 participants from arm 2 were included in the analysis
Baseline characteristics by cohort
| Measure |
Arm 1
n=44 Participants
(arm 1) Eslicarbazepine Acetate (ESL) as first add-on to Levetiracetam or Lamotrigine)
|
Arm 2
n=58 Participants
(arm 2) Eslicarbazepine Acetate (ESL) as later add-on to 1-2 Anti-epileptic drugs (AEDs)
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=44 Participants
|
2 Participants
n=58 Participants
|
2 Participants
n=102 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=44 Participants
|
53 Participants
n=58 Participants
|
91 Participants
n=102 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=44 Participants
|
3 Participants
n=58 Participants
|
9 Participants
n=102 Participants
|
|
Age, Continuous
|
43.1 Years
STANDARD_DEVIATION 15.37 • n=44 Participants
|
42.0 Years
STANDARD_DEVIATION 13.83 • n=58 Participants
|
42.5 Years
STANDARD_DEVIATION 14.45 • n=102 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=44 Participants
|
36 Participants
n=58 Participants
|
60 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=44 Participants
|
22 Participants
n=58 Participants
|
42 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=44 Participants
|
7 Participants
n=58 Participants
|
14 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=44 Participants
|
51 Participants
n=58 Participants
|
88 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=102 Participants
|
|
Age, Customized
> 65 years
|
4 Participants
n=44 Participants
|
3 Participants
n=58 Participants
|
7 Participants
n=102 Participants
|
|
Age, Customized
>=18 - <=65 years
|
40 Participants
n=44 Participants
|
55 Participants
n=58 Participants
|
95 Participants
n=102 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=44 Participants
|
3 Participants
n=58 Participants
|
4 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=44 Participants
|
16 Participants
n=58 Participants
|
24 Participants
n=102 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=44 Participants
|
2 Participants
n=58 Participants
|
8 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=44 Participants
|
36 Participants
n=58 Participants
|
64 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Other
|
1 Participants
n=44 Participants
|
1 Participants
n=58 Participants
|
2 Participants
n=102 Participants
|
|
Country
Canada
|
0 Participants
n=44 Participants
|
3 Participants
n=58 Participants
|
3 Participants
n=102 Participants
|
|
Country
United States
|
44 Participants
n=44 Participants
|
55 Participants
n=58 Participants
|
99 Participants
n=102 Participants
|
|
Duration of Epilepsy
< 20 years
|
37 Participants
n=44 Participants
|
36 Participants
n=58 Participants
|
73 Participants
n=102 Participants
|
|
Duration of Epilepsy
>= 20 years
|
7 Participants
n=44 Participants
|
22 Participants
n=58 Participants
|
29 Participants
n=102 Participants
|
|
Number of Anti-epileptic drugs (AEDs) at Baseline
0
|
1 Participants
n=44 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=102 Participants
|
|
Number of Anti-epileptic drugs (AEDs) at Baseline
1
|
42 Participants
n=44 Participants
|
21 Participants
n=58 Participants
|
63 Participants
n=102 Participants
|
|
Number of Anti-epileptic drugs (AEDs) at Baseline
>=2
|
1 Participants
n=44 Participants
|
37 Participants
n=58 Participants
|
38 Participants
n=102 Participants
|
|
Use of Lamotrigine as Baseline AED
Yes
|
15 Participants
n=44 Participants
|
20 Participants
n=58 Participants
|
35 Participants
n=102 Participants
|
|
Use of Lamotrigine as Baseline AED
No
|
29 Participants
n=44 Participants
|
38 Participants
n=58 Participants
|
67 Participants
n=102 Participants
|
|
Use of Levetiracetam as Baseline AED
Yes
|
28 Participants
n=44 Participants
|
24 Participants
n=58 Participants
|
52 Participants
n=102 Participants
|
|
Use of Levetiracetam as Baseline AED
No
|
16 Participants
n=44 Participants
|
34 Participants
n=58 Participants
|
50 Participants
n=102 Participants
|
|
Use of Carbamazepine as Baseline AED
Yes
|
0 Participants
n=44 Participants
|
5 Participants
n=58 Participants
|
5 Participants
n=102 Participants
|
|
Use of Carbamazepine as Baseline AED
No
|
44 Participants
n=44 Participants
|
53 Participants
n=58 Participants
|
97 Participants
n=102 Participants
|
|
Use of Valproic Acid as Baseline AED
Yes
|
0 Participants
n=44 Participants
|
4 Participants
n=58 Participants
|
4 Participants
n=102 Participants
|
|
Use of Valproic Acid as Baseline AED
No
|
44 Participants
n=44 Participants
|
54 Participants
n=58 Participants
|
98 Participants
n=102 Participants
|
|
Use of Lacosamide as Baseline AED
Yes
|
0 Participants
n=44 Participants
|
11 Participants
n=58 Participants
|
11 Participants
n=102 Participants
|
|
Use of Lacosamide as Baseline AED
No
|
44 Participants
n=44 Participants
|
47 Participants
n=58 Participants
|
91 Participants
n=102 Participants
|
|
Use of Topiramate as Baseline AED
Yes
|
0 Participants
n=44 Participants
|
9 Participants
n=58 Participants
|
9 Participants
n=102 Participants
|
|
Use of Topiramate as Baseline AED
No
|
44 Participants
n=44 Participants
|
49 Participants
n=58 Participants
|
93 Participants
n=102 Participants
|
|
Use of Valproate Semisodium as BL AED
Yes
|
0 Participants
n=44 Participants
|
7 Participants
n=58 Participants
|
7 Participants
n=102 Participants
|
|
Use of Valproate Semisodium as BL AED
No
|
44 Participants
n=44 Participants
|
51 Participants
n=58 Participants
|
95 Participants
n=102 Participants
|
|
Use of Valproate All Forms as BL AED
Yes
|
0 Participants
n=44 Participants
|
11 Participants
n=58 Participants
|
11 Participants
n=102 Participants
|
|
Use of Valproate All Forms as BL AED
No
|
44 Participants
n=44 Participants
|
47 Participants
n=58 Participants
|
91 Participants
n=102 Participants
|
|
Rescue Medications at Baseline
Yes
|
2 Participants
n=44 Participants
|
5 Participants
n=58 Participants
|
7 Participants
n=102 Participants
|
|
Rescue Medications at Baseline
No
|
42 Participants
n=44 Participants
|
53 Participants
n=58 Participants
|
95 Participants
n=102 Participants
|
|
Worst Seizure Type during Baseline
Simple Partial
|
6 Participants
n=44 Participants • for this outcome measure only 57 participants from arm 2 were included in the analysis
|
4 Participants
n=57 Participants • for this outcome measure only 57 participants from arm 2 were included in the analysis
|
10 Participants
n=101 Participants • for this outcome measure only 57 participants from arm 2 were included in the analysis
|
|
Worst Seizure Type during Baseline
Complex Partial
|
25 Participants
n=44 Participants • for this outcome measure only 57 participants from arm 2 were included in the analysis
|
41 Participants
n=57 Participants • for this outcome measure only 57 participants from arm 2 were included in the analysis
|
66 Participants
n=101 Participants • for this outcome measure only 57 participants from arm 2 were included in the analysis
|
|
Worst Seizure Type during Baseline
Partial Evolving to Secondary Generalized
|
12 Participants
n=44 Participants • for this outcome measure only 57 participants from arm 2 were included in the analysis
|
12 Participants
n=57 Participants • for this outcome measure only 57 participants from arm 2 were included in the analysis
|
24 Participants
n=101 Participants • for this outcome measure only 57 participants from arm 2 were included in the analysis
|
|
Worst Seizure Type during Baseline
Other
|
1 Participants
n=44 Participants • for this outcome measure only 57 participants from arm 2 were included in the analysis
|
0 Participants
n=57 Participants • for this outcome measure only 57 participants from arm 2 were included in the analysis
|
1 Participants
n=101 Participants • for this outcome measure only 57 participants from arm 2 were included in the analysis
|
|
Baseline Height (cm)
|
166.9 cm
STANDARD_DEVIATION 11.76 • n=44 Participants
|
166.8 cm
STANDARD_DEVIATION 9.73 • n=58 Participants
|
166.9 cm
STANDARD_DEVIATION 10.59 • n=102 Participants
|
|
Baseline Weight (kg)
|
80.23 kg
STANDARD_DEVIATION 16.620 • n=44 Participants
|
86.24 kg
STANDARD_DEVIATION 23.841 • n=58 Participants
|
83.65 kg
STANDARD_DEVIATION 21.151 • n=102 Participants
|
|
Baseline BMI (kg/m^2)
|
28.83 kg/m^2
STANDARD_DEVIATION 5.694 • n=44 Participants
|
30.83 kg/m^2
STANDARD_DEVIATION 7.618 • n=58 Participants
|
29.97 kg/m^2
STANDARD_DEVIATION 6.895 • n=102 Participants
|
|
Duration of Epilepsy (years)
|
9.4 years
STANDARD_DEVIATION 11.10 • n=44 Participants
|
19.5 years
STANDARD_DEVIATION 15.90 • n=58 Participants
|
15.1 years
STANDARD_DEVIATION 14.85 • n=102 Participants
|
|
Number of Anti-epileptic drugs (AEDs) at Baseline
|
1 number of Anti-epileptic drugs (AEDs)
STANDARD_DEVIATION 0.22 • n=44 Participants
|
1.7 number of Anti-epileptic drugs (AEDs)
STANDARD_DEVIATION 0.62 • n=58 Participants
|
1.4 number of Anti-epileptic drugs (AEDs)
STANDARD_DEVIATION 0.6 • n=102 Participants
|
PRIMARY outcome
Timeframe: From the date of the first dose of the study drug until the completion of 24 weeks Maintenance PhasePhase 4 study of eslicarbazepine acetate (ESL) as adjunctive therapy in adult subjects with a diagnosis of epilepsy with Partial-onset seizures (POS). Two groups of ESL-naïve subjects will be evaluated
Outcome measures
| Measure |
Eslicarbazepine Acetate (Arm 1)
n=44 Participants
eslicarbazepine acetate (ESL) (as first add-on to Levetiracetam or Lamotrigine)
|
Eslicarbazepine Acetate (Arm 2)
n=58 Participants
eslicarbazepine acetate (ESL) (as later add-on to 1-2 Anti-epileptic drugs (AEDs)
|
|---|---|---|
|
The Number of Subjects Completing 24 Weeks Adjunctive Therapy During Maintenance Phase
|
36 participants
|
37 participants
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm 2
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=44 participants at risk
(arm 1) Eslicarbazepine Acetate (ESL) as first add-on to Levetiracetam or Lamotrigine)
|
Arm 2
n=58 participants at risk
(arm 2) Eslicarbazepine Acetate (ESL) as later add-on to 1-2 Anti-epileptic drugs (AEDs)
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/44 • 31 weeks
|
1.7%
1/58 • Number of events 1 • 31 weeks
|
|
Nervous system disorders
Convulsion
|
0.00%
0/44 • 31 weeks
|
1.7%
1/58 • Number of events 1 • 31 weeks
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/44 • 31 weeks
|
1.7%
1/58 • Number of events 1 • 31 weeks
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/44 • 31 weeks
|
1.7%
1/58 • Number of events 1 • 31 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/44 • 31 weeks
|
1.7%
1/58 • Number of events 1 • 31 weeks
|
Other adverse events
| Measure |
Arm 1
n=44 participants at risk
(arm 1) Eslicarbazepine Acetate (ESL) as first add-on to Levetiracetam or Lamotrigine)
|
Arm 2
n=58 participants at risk
(arm 2) Eslicarbazepine Acetate (ESL) as later add-on to 1-2 Anti-epileptic drugs (AEDs)
|
|---|---|---|
|
Eye disorders
Diplopia
|
2.3%
1/44 • Number of events 1 • 31 weeks
|
6.9%
4/58 • Number of events 7 • 31 weeks
|
|
Gastrointestinal disorders
Nausea
|
9.1%
4/44 • Number of events 4 • 31 weeks
|
19.0%
11/58 • Number of events 13 • 31 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/44 • Number of events 1 • 31 weeks
|
10.3%
6/58 • Number of events 7 • 31 weeks
|
|
General disorders
Fatigue
|
4.5%
2/44 • Number of events 2 • 31 weeks
|
15.5%
9/58 • Number of events 10 • 31 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/44 • 31 weeks
|
5.2%
3/58 • Number of events 3 • 31 weeks
|
|
Infections and infestations
Nasopharyngitis
|
13.6%
6/44 • Number of events 6 • 31 weeks
|
3.4%
2/58 • Number of events 2 • 31 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
1/44 • Number of events 1 • 31 weeks
|
5.2%
3/58 • Number of events 3 • 31 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
3/44 • Number of events 3 • 31 weeks
|
3.4%
2/58 • Number of events 2 • 31 weeks
|
|
Nervous system disorders
Balance disorder
|
4.5%
2/44 • Number of events 2 • 31 weeks
|
5.2%
3/58 • Number of events 3 • 31 weeks
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/44 • 31 weeks
|
5.2%
3/58 • Number of events 3 • 31 weeks
|
|
Nervous system disorders
Dizziness
|
18.2%
8/44 • Number of events 10 • 31 weeks
|
24.1%
14/58 • Number of events 15 • 31 weeks
|
|
Nervous system disorders
Headache
|
11.4%
5/44 • Number of events 5 • 31 weeks
|
13.8%
8/58 • Number of events 15 • 31 weeks
|
|
Nervous system disorders
Memory impairment
|
2.3%
1/44 • Number of events 1 • 31 weeks
|
6.9%
4/58 • Number of events 5 • 31 weeks
|
|
Nervous system disorders
Somnolence
|
13.6%
6/44 • Number of events 6 • 31 weeks
|
10.3%
6/58 • Number of events 6 • 31 weeks
|
|
Psychiatric disorders
Anxiety
|
2.3%
1/44 • Number of events 2 • 31 weeks
|
10.3%
6/58 • Number of events 6 • 31 weeks
|
|
Vascular disorders
Haematoma
|
0.00%
0/44 • 31 weeks
|
5.2%
3/58 • Number of events 4 • 31 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming withing twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish
- Publication restrictions are in place
Restriction type: OTHER