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

NCT00981227 | Completed Phase 2 Results

• 1 other identifier: BIA-2093-207
• Study Type: interventional
• Target: 567
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postherpetic Neuralgia

Keywords

pain herpetic neuralgia

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose

  baseline and 13 weeks

Study Arms (6)

ESL 400 mg twice-daily

EXPERIMENTAL

ESL 400 mg twice-daily

Drug: Eslicarbazepine acetate

ESL 800 mg once-daily

EXPERIMENTAL

ESL 800 mg once-daily

Drug: Eslicarbazepine acetate

ESL 600 mg twice daily

EXPERIMENTAL

ESL 600 mg twice daily

Drug: Eslicarbazepine acetate

ESL 1200 mg once daily

EXPERIMENTAL

ESL 1200 mg once daily

Drug: Eslicarbazepine acetate

ESL 800 mg twice daily

EXPERIMENTAL

ESL 800 mg twice daily

Drug: Eslicarbazepine acetate

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Eslicarbazepine acetate DRUG

Scored tablets

Also known as: Zebinix

ESL 1200 mg once daily; ESL 400 mg twice-daily; ESL 600 mg twice daily; ESL 800 mg once-daily; ESL 800 mg twice daily

Placebo DRUG

oral route

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Head of Clinical Research Section
• Organization: Bial-Portela & Cª, S.A.

clinical.trials@bial.com

+351 22 986 6100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 22, 2009
• Study Start: November 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: October 29, 2014
• Results First Posted: May 3, 2013

Record last verified: 2014-10