Phase 2
N=567
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia
Postherpetic Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT00981227 ↗Enrolled (actual)
567
Serious AEs
2.1%
Results posted
May 2013
Primary outcome: Primary: Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain — -1.9447; -1.9786; -1.6798; -1.6633 Points
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Eslicarbazepine acetate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bial - Portela C S.A.
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain |
-1.9447; -1.9786; -1.6798; -1.6633; -2.0834; -1.5441 | — |
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 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 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.
Data sourced from ClinicalTrials.gov (NCT00981227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.