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

Postherpetic Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981227
• Other study ID #: BIA-2093-207
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2009
• Last updated: October 21, 2014
• Start date: November 2007
• Est. completion date: January 2009

Study information

• Verified date: October 2014
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• Eslicarbazepine acetate
Scored tablets
• Placebo
oral route

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose	Details of neuropathic pain, as recorded in a subject diary, were used for the primary assessment of analgesic efficacy. Subjects assessed their pain using an 11-point (0 "no pain" to 10 "worst possible pain") NRPS upon awakening each morning and recorded the results in the subject diary. This score reflected the subject's mean pain over the previous 24 hours. Subjects were trained how to record their pain reliably. Investigators were trained in the subject's NRPS use during site initiation visits and at the investigators' meeting.	baseline and 13 weeks	No
Primary	Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain	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.	baseline and 13 weeks	No