Trial Outcomes & Findings for Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients (NCT NCT01422720)

Last Updated: 2017-08-07

Results Overview

An AE was defined as Treatment-Emergent Adverse Event (TEAE), if first onset or worsening was after the first intake of investigational medicinal product (IMP) and not more than 14 days after the last administration of IMP. TEAE assessment: * patients who died * patients who died due to Treatment-emergent adverse event (TEAE) * patients with at least one Serious Adverse Event (SAE) * patients with at least one Treatment-emergent Serious Adverse Event (TESAE) * patients prematurely terminated due to TEAE * patients with at least one TEAE * patients with at least one related TEAE * patients with at least one severe TEAE * patients without any TEAE

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

72 participants

Primary outcome timeframe

throughout the study

Results posted on

2017-08-07

Participant Flow

44 clinical centres in Europe and Asia. Studied period (years): Date of first enrolment: 19-APR-2010 Date of last subject completed: 08-OCT-2013

In this trial all subjects received the same treatment.

Participant milestones

Participant milestones
Measure	Esl 800 mg Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
Overall Study STARTED	72
Overall Study Safety Set	72
Overall Study Full Analysis Set (FAS)	71
Overall Study Per-Protocol Set (PPS)	55
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Esl 800 mg Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
Overall Study Adverse Event	16
Overall Study Lack of Efficacy	1
Overall Study Withdrawal by Subject	4
Overall Study Ineligibility	1

Baseline Characteristics

Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esl 800 mg n=72 Participants Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
Age, Customized 65-69 years	30 participants n=5 Participants
Age, Customized 70-74 years	19 participants n=5 Participants
Age, Customized 75-79 years	19 participants n=5 Participants
Age, Customized 80-84 years	4 participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: throughout the study

Outcome measures

Outcome measures
Measure	Esl 800 mg n=72 Participants Eslicarbazepine Acetate (Esl) tablets (800 mg) QD	FAS - Treatment Period The Full Analysis Set (FAS) consisted of all subjects who received at least one dose of IMP and had at least one day of seizure evaluation reported in the patient diary after Visit 2.	PPS - Baseline Period The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.	PPS- Treatment Period The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
Number of Subjects With Reported Adverse Events (AE) patients who died	3 participants	—	—	—
Number of Subjects With Reported Adverse Events (AE) patients who died due to TEAE	3 participants	—	—	—
Number of Subjects With Reported Adverse Events (AE) patients with at least one SAE	11 participants	—	—	—
Number of Subjects With Reported Adverse Events (AE) patients with at least one TESAE	10 participants	—	—	—
Number of Subjects With Reported Adverse Events (AE) patients prematurely terminated due to TEAE	18 participants	—	—	—
Number of Subjects With Reported Adverse Events (AE) patients with at least one TEAE	47 participants	—	—	—
Number of Subjects With Reported Adverse Events (AE) patients with at least one related TEAE	31 participants	—	—	—
Number of Subjects With Reported Adverse Events (AE) patients without any TEAE	25 participants	—	—	—
Number of Subjects With Reported Adverse Events (AE) patients with at least one severe TEAE	12 participants	—	—	—

SECONDARY outcome

Timeframe: 8-week Baseline Period and 26-week Treatment Period

Absolute and relative changes from baseline of seizure frequency standardised to a frequency per 4 weeks.

Outcome measures

Outcome measures
Measure	Esl 800 mg n=71 Participants Eslicarbazepine Acetate (Esl) tablets (800 mg) QD	FAS - Treatment Period n=71 Participants The Full Analysis Set (FAS) consisted of all subjects who received at least one dose of IMP and had at least one day of seizure evaluation reported in the patient diary after Visit 2.	PPS - Baseline Period n=55 Participants The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.	PPS- Treatment Period n=55 Participants The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
Change From Baseline in Standardized Seizure Frequency	4.8 seizures/4 weeks Standard Deviation 5.53	3.6 seizures/4 weeks Standard Deviation 5.84	4.0 seizures/4 weeks Standard Deviation 3.54	3.1 seizures/4 weeks Standard Deviation 5.64

Adverse Events

Esl 800 mg

Serious events: 11 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Esl 800 mg n=72 participants at risk Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
Nervous system disorders Altered state of consciousness	1.4% 1/72 • Number of events 1 • Throughout the study
Nervous system disorders Grand mal convulsion	2.8% 2/72 • Number of events 2 • Throughout the study
Nervous system disorders Ischaemic stroke	1.4% 1/72 • Number of events 1 • Throughout the study
Nervous system disorders Lacunar infarction	1.4% 1/72 • Number of events 1 • Throughout the study
Nervous system disorders Presyncope	1.4% 1/72 • Number of events 1 • Throughout the study
Infections and infestations Bronchitis	1.4% 1/72 • Number of events 1 • Throughout the study
Infections and infestations Gastroenteritis	1.4% 1/72 • Number of events 1 • Throughout the study
Infections and infestations Pneumonia	1.4% 1/72 • Number of events 1 • Throughout the study
Cardiac disorders Cardiac failure	1.4% 1/72 • Number of events 1 • Throughout the study
Cardiac disorders Coronary artery disease	1.4% 1/72 • Throughout the study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	1.4% 1/72 • Number of events 1 • Throughout the study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.4% 1/72 • Throughout the study
Injury, poisoning and procedural complications Toxicity to various agents	1.4% 1/72 • Number of events 1 • Throughout the study
Metabolism and nutrition disorders Hyponatraemia	1.4% 1/72 • Number of events 1 • Throughout the study
Psychiatric disorders Postictal psychosis	1.4% 1/72 • Number of events 1 • Throughout the study
Respiratory, thoracic and mediastinal disorders Upper airway obstruction	1.4% 1/72 • Number of events 1 • Throughout the study
Gastrointestinal disorders Gastritis	1.4% 1/72 • Number of events 1 • Throughout the study
Injury, poisoning and procedural complications Craniocerebral injury	1.4% 1/72 • Number of events 1 • Throughout the study

Other adverse events

Other adverse events
Measure	Esl 800 mg n=72 participants at risk Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
Nervous system disorders Dizziness	12.5% 9/72 • Number of events 11 • Throughout the study
Nervous system disorders Somnolence	9.7% 7/72 • Number of events 7 • Throughout the study
General disorders Fatigue	8.3% 6/72 • Number of events 7 • Throughout the study
Nervous system disorders Convulsion	8.3% 6/72 • Number of events 6 • Throughout the study
Metabolism and nutrition disorders Hyponatraemia	8.3% 6/72 • Number of events 6 • Throughout the study
Infections and infestations Nasopharyngitis	6.9% 5/72 • Number of events 5 • Throughout the study
Infections and infestations Upper respiratory tract infection	5.6% 4/72 • Number of events 5 • Throughout the study

Additional Information

Director R&D

BIAL - Portela & Cª S.A.

Phone: +351-229866100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER