Efficacy and Safety of Eslicarbazepine… | Clinical Trial

Key information

Conditions

Postherpetic Neuralgia Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written informed consent to participate in the study
Men and women aged 18 years or older
Previous diagnosis of herpes zoster
Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
Cooperation and willingness to complete all aspects of the study
Completion of at least 4 daily diaries during the week preceding randomisation
A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion criteria

Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
Active herpes zoster lesion or dermatitis of any origin at the affected site
Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
Previous participation in any study with eslicarbazepine acetate
Pregnancy or breast feeding
History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
History of non-compliance
Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
Participation in a clinical study within 3 months prior to screening
Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.

Treatment and study plan

eslicarbazepine acetate

Drug

Scored tablets

Other names: Zebinix

Placebo

Drug

oral route

Primary outcomes

Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain

Time frame: baseline and 13 weeks
The primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. This score should reflect the patient's mean pain over the previous 24 hours.

Please note that the change from baseline to endpoint in mean pain, i.e. the difference between endpoint mean pain and baseline mean pain, which are defined as follows:
- Baseline mean pain is defined as the mean of the last four available ratings of average daily pain (NRPS) in the patient diary performed in the last 7 days before randomisation.
- Endpoint mean pain is defined as the mean of the last four available ratings of average daily pain in the patient diary in the last 7 days of the treatment period.

Other outcomes

Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose

Time frame: baseline and 13 weeks

Details of neuropathic pain, as recorded in a subject diary, were used for the primary assessment of analgesic efficacy. Subjects assessed their pain using an 11-point (0 "no pain" to 10 "worst possible pain") NRPS upon awakening each morning and recorded the results in the subject diary. This score reflected the subject's mean pain over the previous 24 hours. Subjects were trained how to record their pain reliably. Investigators were trained in the subject's NRPS use during site initiation visits and at the investigators' meeting.

Sponsors and collaborators

Lead sponsor

Bial - Portela C S.A.

Industry

Registry information

Official study title

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2093) as Therapy for Patients With Post-herpetic Neuralgia: a Double-blind, Double-dummy, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Sep 22, 2009
Registry last updated: Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed