Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia

BIAL

Status and phase: Completed; Phase 2

Conditions: Postherpetic Neuralgia

Treatments: Drug: Eslicarbazepine acetate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00981227

BIA-2093-207

Details and patient eligibility

About

The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with post-herpetic neuralgia.

Enrollment: 567 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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567 participants in 6 patient groups, including a placebo group

ESL 400 mg twice-daily

Experimental group

Description:

ESL 400 mg twice-daily

Treatment:

Drug: Eslicarbazepine acetate

ESL 800 mg once-daily

Experimental group

Description:

ESL 800 mg once-daily

Treatment:

Drug: Eslicarbazepine acetate

ESL 600 mg twice daily

Experimental group

Description:

ESL 600 mg twice daily

Treatment:

Drug: Eslicarbazepine acetate

ESL 1200 mg once daily

Experimental group

Description:

ESL 1200 mg once daily

Treatment:

Drug: Eslicarbazepine acetate

ESL 800 mg twice daily

Experimental group

Description:

ESL 800 mg twice daily

Treatment:

Drug: Eslicarbazepine acetate

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo