Trial Outcomes & Findings for Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia (NCT NCT01124097)

Last Updated: 2014-04-07

Results Overview

The efficacy analysis was restricted to the primary efficacy variable in the analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (October 31, 2011), was the basis for the analysis. The primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 \["0" = no pain; "10" = the most intense pain imaginable\]

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

240 participants

Primary outcome timeframe

baseline to endpoint

Results posted on

2014-04-07

Participant Flow

Eighty nine (89) clinical sites in 12 countries Study period: Date of first admission: 2010.09.28 Date of last visit: 2012.04.23

Participant milestones

Participant milestones
Measure	Esl 1600 mg QD Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Esl 1200 mg QD Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Esl 800 mg Once Daily (QD) Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Placebo Placebo: Tablets will be used.
Overall Study STARTED	60	60	60	60
Overall Study Safety Population	60	60	60	60
Overall Study Efficacy Population	52	53	53	51
Overall Study COMPLETED	26	38	40	46
Overall Study NOT COMPLETED	34	22	20	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Esl 1600 mg QD Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Esl 1200 mg QD Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Esl 800 mg Once Daily (QD) Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Placebo Placebo: Tablets will be used.
Overall Study Withdrawal by Subject	4	3	2	3
Overall Study Lack of Efficacy	2	3	1	3
Overall Study Adverse Event	24	15	15	7
Overall Study Protocol Violation	2	0	2	1
Overall Study Physician Decision	2	1	0	0

Baseline Characteristics

Eslicarbazepine Acetate as Therapy in Post-Herpetic Neuralgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esl 1600 mg QD n=60 Participants Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Esl 1200 mg QD n=60 Participants Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Esl 800 mg Once Daily (QD) n=60 Participants Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Placebo n=60 Participants Placebo: Tablets will be used.	Total n=240 Participants Total of all reporting groups
Age, Continuous	63.2 years STANDARD_DEVIATION 16.71 • n=5 Participants	65.4 years STANDARD_DEVIATION 14.47 • n=7 Participants	65.9 years STANDARD_DEVIATION 15.6 • n=5 Participants	65.4 years STANDARD_DEVIATION 14.43 • n=4 Participants	64.9 years STANDARD_DEVIATION 15.27 • n=21 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	23 Participants n=7 Participants	35 Participants n=5 Participants	25 Participants n=4 Participants	107 Participants n=21 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	37 Participants n=7 Participants	25 Participants n=5 Participants	35 Participants n=4 Participants	133 Participants n=21 Participants

PRIMARY outcome

Timeframe: baseline to endpoint

Population: efficacy population

Outcome measures

Outcome measures
Measure	Esl 1600 mg QD n=52 Participants Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Esl 1200 mg QD n=53 Participants Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Esl 800 mg Once Daily (QD) n=53 Participants Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Placebo n=51 Participants Placebo: Tablets will be used.
Change From Baseline to Endpoint in Mean Pain	-1.19 units on a scale Standard Error 0.290	-1.34 units on a scale Standard Error 0.277	-0.94 units on a scale Standard Error 0.281	-0.77 units on a scale Standard Error 0.293

Adverse Events

Esl 1600 mg QD

Serious events: 2 serious events

Other events: 46 other events

Deaths: 0 deaths

Esl 1200 mg QD

Serious events: 6 serious events

Other events: 45 other events

Deaths: 0 deaths

Esl 800 mg Once Daily (QD)

Serious events: 4 serious events

Other events: 40 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Esl 1600 mg QD n=60 participants at risk Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Esl 1200 mg QD n=60 participants at risk Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Esl 800 mg Once Daily (QD) n=60 participants at risk Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Placebo n=60 participants at risk Placebo: Tablets will be used.
Nervous system disorders Dizziness	21.7% 13/60 • Number of events 15 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	10.0% 6/60 • Number of events 6 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	10.0% 6/60 • Number of events 6 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Gastrointestinal disorders Nausea	13.3% 8/60 • Number of events 8 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	5.0% 3/60 • Number of events 3 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	18.3% 11/60 • Number of events 11 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Nervous system disorders Headache	16.7% 10/60 • Number of events 11 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	11.7% 7/60 • Number of events 8 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	5.0% 3/60 • Number of events 4 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	3.3% 2/60 • Number of events 2 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Metabolism and nutrition disorders Hyponatraemia	10.0% 6/60 • Number of events 7 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	6.7% 4/60 • Number of events 4 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	6.7% 4/60 • Number of events 4 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Ear and labyrinth disorders Vertigo	10.0% 6/60 • Number of events 6 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	5.0% 3/60 • Number of events 4 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	3.3% 2/60 • Number of events 2 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • Number of events 1 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
General disorders Fatigue	10.0% 6/60 • Number of events 6 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	3.3% 2/60 • Number of events 2 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	3.3% 2/60 • Number of events 2 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • Number of events 1 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Investigations Gamma-glutamyltransferase increased	8.3% 5/60 • Number of events 5 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	6.7% 4/60 • Number of events 4 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Gastrointestinal disorders Constipation	5.0% 3/60 • Number of events 4 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	8.3% 5/60 • Number of events 5 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • Number of events 1 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • Number of events 1 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Skin and subcutaneous tissue disorders Rash	5.0% 3/60 • Number of events 3 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	6.7% 4/60 • Number of events 4 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	3.3% 2/60 • Number of events 4 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • Number of events 1 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Nervous system disorders Somnolence	5.0% 3/60 • Number of events 4 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	5.0% 3/60 • Number of events 4 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	3.3% 2/60 • Number of events 4 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Gastrointestinal disorders Vomiting	3.3% 2/60 • Number of events 2 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • Number of events 1 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	6.7% 4/60 • Number of events 4 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Metabolism and nutrition disorders Decreased appetite	3.3% 2/60 • Number of events 2 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	5.0% 3/60 • Number of events 3 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Vascular disorders Hypertension	3.3% 2/60 • Number of events 2 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	5.0% 3/60 • Number of events 3 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)

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

Measure	Esl 1600 mg QD n=60 participants at risk Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Esl 1200 mg QD n=60 participants at risk Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Esl 800 mg Once Daily (QD) n=60 participants at risk Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.	Placebo n=60 participants at risk Placebo: Tablets will be used.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Nervous system disorders Cerebral haematoma	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Nervous system disorders Dizziness	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Nervous system disorders Syncope	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	3.3% 2/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Psychiatric disorders Suicidal ideation	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Vascular disorders Hypertensive crisis	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Cardiac disorders Atrial fibrillation	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Cardiac disorders Ventricular extrasystoles	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Immune system disorders Drug hypersensitivity	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Infections and infestations Pneumonia	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	3.3% 2/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Infections and infestations Urosepsis	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Injury, poisoning and procedural complications Chest injury	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	1.7% 1/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)	0.00% 0/60 • participants were followed an average of 55 weeks (19 weeks DB + 36 weeks OL)