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
Overview
- Phase
- Phase 2
- Intervention
- Eslicarbazepine acetate
- Conditions
- Postherpetic Neuralgia
- Sponsor
- Bial - Portela C S.A.
- Enrollment
- 567
- Primary Endpoint
- Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
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
Arms & Interventions
ESL 400 mg twice-daily
ESL 400 mg twice-daily
Intervention: Eslicarbazepine acetate
ESL 800 mg once-daily
ESL 800 mg once-daily
Intervention: Eslicarbazepine acetate
ESL 600 mg twice daily
ESL 600 mg twice daily
Intervention: Eslicarbazepine acetate
ESL 1200 mg once daily
ESL 1200 mg once daily
Intervention: Eslicarbazepine acetate
ESL 800 mg twice daily
ESL 800 mg twice daily
Intervention: Eslicarbazepine acetate
placebo
placebo
Intervention: Placebo
Outcomes
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.