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Phase 2 N=567 Randomized Quadruple-blind Treatment

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

Postherpetic Neuralgia

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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