Status:
COMPLETED
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Postherpetic Neuralgia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
567 Patients enrolled
Trial Details
Trial ID
NCT00981227
Start Date
November 1 2007
End Date
January 1 2009
Last Update
October 29 2014
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