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

Sponsor:	Bial - Portela C S.A.
Information provided by:	Bial - Portela C S.A.
ClinicalTrials.gov Identifier:	NCT00981227

Purpose

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

Condition	Intervention	Phase
Postherpetic Neuralgia	Drug: Eslicarbazepine acetate Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Shingles

Drug Information available for: Eslicarbazepine

U.S. FDA Resources

Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:

The primary efficacy variable will be the change from baseline to endpoint in mean pain, recorded daily by the patient on a numerical scale. [ Time Frame: Duration per patient: up to 13 weeks (up to 2-week baseline; 1-week titration period, 8-week maintenance period, 2 weeks safety follow-up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

responder rates (defined as a reduction in endpoint mean pain by at least 30% or at least 50% with respect to baseline) [ Time Frame: Duration per patient: up to 13 weeks (up to 2-week baseline; 1-week titration period, 8-week maintenance period, 2 weeks safety follow-up) ] [ Designated as safety issue: No ]
daily mean pain intensity [ Time Frame: Duration per patient: up to 13 weeks (up to 2-week baseline; 1-week titration period, 8-week maintenance period, 2 weeks safety follow-up) ] [ Designated as safety issue: No ]
weekly mean pain intensity [ Time Frame: Duration per patient: up to 13 weeks (up to 2-week baseline; 1-week titration period, 8-week maintenance period, 2 weeks safety follow-up) ] [ Designated as safety issue: No ]
onset of therapeutic effect [ Time Frame: Duration per patient: up to 13 weeks (up to 2-week baseline; 1-week titration period, 8-week maintenance period, 2 weeks safety follow-up) ] [ Designated as safety issue: No ]
pain assessed via the sensory portion of the Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Duration per patient: up to 13 weeks (up to 2-week baseline; 1-week titration period, 8-week maintenance period, 2 weeks safety follow-up) ] [ Designated as safety issue: No ]
Patient Global Impression of Change (PGIC) [ Time Frame: Duration per patient: up to 13 weeks (up to 2-week baseline; 1-week titration period, 8-week maintenance period, 2 weeks safety follow-up) ] [ Designated as safety issue: No ]
the dynamic allodynia (evoked pain) assessed by the Allodynia Severity Rating Scale, [ Time Frame: Duration per patient: up to 13 weeks (up to 2-week baseline; 1-week titration period, 8-week maintenance period, 2 weeks safety follow-up) ] [ Designated as safety issue: No ]
sleep interference assessed by the Chronic Pain Sleep Inventory (CPSI®) [ Time Frame: Duration per patient: up to 13 weeks (up to 2-week baseline; 1-week titration period, 8-week maintenance period, 2 weeks safety follow-up) ] [ Designated as safety issue: No ]
quality of life assessed by the SF-36 Health Survey [ Time Frame: Duration per patient: up to 13 weeks (up to 2-week baseline; 1-week titration period, 8-week maintenance period, 2 weeks safety follow-up) ] [ Designated as safety issue: No ]
intake of rescue medication [ Time Frame: Duration per patient: up to 13 weeks (up to 2-week baseline; 1-week titration period, 8-week maintenance period, 2 weeks safety follow-up) ] [ Designated as safety issue: No ]
adverse events (AEs), standard laboratory safety data (haematology, biochemistry), 12-lead electrocardiogram (ECG), vital signs (blood pressure, heart rate), physical and neurological examinations [ Time Frame: Duration per patient: up to 13 weeks (up to 2-week baseline; 1-week titration period, 8-week maintenance period, 2 weeks safety follow-up) ] [ Designated as safety issue: Yes ]

Enrollment:	568
Study Start Date:	November 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ESL 400 mg twice-daily: Experimental ESL 400 mg twice-daily	Drug: Eslicarbazepine acetate Scored tablets
ESL 800 mg once-daily: Experimental ESL 800 mg once-daily	Drug: Eslicarbazepine acetate Scored tablets
ESL 600 mg twice daily: Experimental ESL 600 mg twice daily	Drug: Eslicarbazepine acetate Scored tablets
ESL 1200 mg once daily: Experimental ESL 1200 mg once daily	Drug: Eslicarbazepine acetate Scored tablets
ESL 800 mg twice daily: Experimental ESL 800 mg twice daily	Drug: Eslicarbazepine acetate Scored tablets
placebo: Placebo Comparator placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 < 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Bial - Portela & Cª, S.A ( Patricio Soares-da-Silva/Department of Research and Development )
Study ID Numbers:	BIA-2093-207
Study First Received:	September 18, 2009
Last Updated:	September 21, 2009
ClinicalTrials.gov Identifier:	NCT00981227 History of Changes
Health Authority:	Austria: Ethikkommission

Keywords provided by Bial - Portela C S.A.:

pain herpetic neuralgia

Additional relevant MeSH terms:

Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia

Peripheral Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Pain

ClinicalTrials.gov processed this record on November 20, 2009