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

NCT ID: NCT00981227

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 567 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-01-31

Brief Summary

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

Conditions

Postherpetic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ESL 400 mg twice-daily

ESL 400 mg twice-daily

Group Type: EXPERIMENTAL

Eslicarbazepine acetate

Intervention Type: DRUG

Scored tablets

ESL 800 mg once-daily

ESL 800 mg once-daily

Group Type: EXPERIMENTAL

Eslicarbazepine acetate

Intervention Type: DRUG

Scored tablets

ESL 600 mg twice daily

ESL 600 mg twice daily

Group Type: EXPERIMENTAL

Eslicarbazepine acetate

Intervention Type: DRUG

Scored tablets

ESL 1200 mg once daily

ESL 1200 mg once daily

Group Type: EXPERIMENTAL

Eslicarbazepine acetate

Intervention Type: DRUG

Scored tablets

ESL 800 mg twice daily

ESL 800 mg twice daily

Group Type: EXPERIMENTAL

Eslicarbazepine acetate

Intervention Type: DRUG

Scored tablets

placebo

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral route

Interventions

Eslicarbazepine acetate

Scored tablets

Intervention Type: DRUG

Placebo

oral route

Intervention Type: DRUG

Other Intervention Names

Zebinix

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BIA-2093-207

Identifier Type: -

Identifier Source: org_study_id