Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01124097
Other study ID # BIA-2093-308
Secondary ID 2010-019101-42
Status Terminated
Phase Phase 3
First received May 3, 2010
Last updated February 26, 2014
Start date September 2010
Est. completion date April 2012

Study information

Verified date February 2014
Source Bial - Portela C S.A.
Contact n/a
Is FDA regulated No
Health authority Austria: EthikkommissionGermany: Federal Institute for Drugs and Medical DevicesChile: Instituto de Salud Pública de ChileArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaIsrael: Ministry of HealthPoland: Ministry of HealthMexico: Secretaria de SaludRussia: Pharmacological Committee, Ministry of HealthIndia: Ministry of HealthSouth Africa: Medicines Control CouncilCzech Republic: State Institute for Drug ControlUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate (ESL) as therapy in subjects with Post-herpetic Neuralgia (PHN) over a 15 week treatment phase.


Description:

Post-herpetic neuralgia (PHN) is a syndrome of intractable pain following an acute infection of herpes zoster (shingles).

Treatment for PHN is often suboptimal. More than 50% of the subjects fail to respond to pharmacological treatments or experience intolerable side effects.

The clinical development of ESL to treat neuropathic pain is based on its chemical and pharmacodynamic relationship to sodium channel blockers, including carbamazepine, which is effective for treating some neuropathic pain conditions. Preclinical data supports the theoretical background.

This study will examine the efficacy, safety, tolerability and pharmacokinetics of Eslicarbazepine acetate for the treatment of post herpetic neuralgia.


Recruitment information / eligibility

Status Terminated
Enrollment 240
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male and female outpatients aged 18 years or older. Female subjects are of nonchildbearing potential, defined as surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or at least 2 years postmenopausal (spontaneous amenorrhea for at least 24 months before Visit 1), or if of childbearing potential, subjects agree to use a medically acceptable nonhormonal method of contraception.

- Experiencing pain for at least 6 months after the healing of a herpes zoster skin rash.

- A mean score between 4.0 and 9.0, inclusive, on the 24 hour average pain intensity assessment.

- Compliance with patient diary completion.

- If not used to treat PHN, subjects are permitted to take nonsteroidal anti inflammatory drugs and selective serotonin reuptake inhibitors if they were kept on a stable dose for 1 month prior to Screening and are foreseen to remain stable throughout the study.

- Competent and able to freely give own informed consent.

- Female subjects of childbearing potential, who are not currently breastfeeding, must have a negative serum pregnancy test at Visit 1.

Exclusion Criteria:

- Historical exposure to drugs known to cause neuropathy

- Significant skin lesions (active infection, ulcer, etc).

- Known intolerance to ESL or to other carboxamide derivatives (eg, carbamazepine or oxcarbazepine) or frequent or severe allergic reactions with multiple medications.

- Subjects who previously participated in a clinical study with ESL.

- Major psychiatric disorder.

- Serious or unstable cardiovascular disease that could compromise participation or cause hospitalization during the study.

- Second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead electrocardiogram as determined by the investigator.

- Subjects taking the following drug classes and individual drugs are excluded: benzodiazepines (except short half life sleep agents), skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletine, centrally acting analgesics (dextromethorphan, tramadol), opiates, topical lidocaine, anticonvulsants, tricyclic antidepressants, and serotonin norepinephrine reuptake inhibitors. These drugs require a minimum washout period of at least 5 times the half life and should be tapered appropriately using product label instructions as a guide.

- Relevant clinical laboratory abnormality that, in the investigator's opinion, can compromise the subject's safety.

- History of drug abuse or dependence (drug categories defined by DSM IV) within the past year, excluding nicotine and caffeine.

- Subjects who, in the previous 30 days, received treatment with a drug that had not received regulatory approval for any indication at the time of study entry.

- History of recurrent epileptic seizures except febrile seizures.

- History of severe gastroparesis or gastric bypass surgery.

- Neurolytic or neurosurgical treatment for PHN.

- Injected anesthetics or steroid use within 30 days of Visit 1.

- Malignancy within past 2 years.

- History of chronic hepatitis B or C within the past 3 months or human immunodeficiency virus infection.

Study Design

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


Intervention

Drug:
Eslicarbazepine acetate (BIA 2-093)
Tablets will be used.
Placebo
Tablets will be used.

Locations

Country Name City State
Germany Synexus ClinPharm GmbH Berlin

Sponsors (1)

Lead Sponsor Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline to Endpoint in Mean Pain The efficacy analysis was restricted to the primary efficacy variable in the analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (October 31, 2011), was the basis for the analysis.
The primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 ["0" = no pain; "10" = the most intense pain imaginable]
baseline to endpoint No
See also
  Status Clinical Trial Phase
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT01426230 - Phase IV Study of FDA Approved, Once-Daily GRALISEā„¢(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia N/A
Completed NCT03974438 - Acupuncture as Treatment of Post-herpetic Neuralgia: A RCT A Double-blinded Randomized Clinical Trial. N/A
Recruiting NCT04144972 - Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain N/A
Completed NCT03447756 - Titration Study of ABX-1431 Phase 1
Recruiting NCT06155487 - A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administration of AJH-2947 in Healthy Korean and/or Caucasian Adult Male Subjects Phase 1
Recruiting NCT06218784 - A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients. Phase 1
Completed NCT03584061 - Treatment of Chronic Postherpetic Pain With Fat Grafting N/A
Completed NCT01270828 - Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia Phase 3
Enrolling by invitation NCT06410222 - Predictive Models for the Treatment of Recurrent Herpes Zoster Neuralgia Following Spinal Cord Electrical Stimulation.
Recruiting NCT05754190 - Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
Completed NCT00475904 - A Comparison of EpiCeptā„¢ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN) Phase 2
Completed NCT03765697 - A Study With Lidocaine 5% Medicated Plaster in Patients Suffering From Postherpetic Neuralgia Phase 3
Not yet recruiting NCT06130514 - The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Sympathetic Ganglion Block N/A
Completed NCT01748877 - Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia Phase 2
Active, not recruiting NCT06241820 - The Success of Lumbar Sympathetic Ganglion Block Using Lower Extremity Perfusion Index N/A
Completed NCT03745404 - A Study With Lido-Patch and Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN) Phase 3