Postherpetic NeuralgiaPhase 2NCT00981227
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia
A Phase 2 study testing Eslicarbazepine acetate in people with Postherpetic Neuralgia, run by Bial - Portela C S.A..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- Eslicarbazepine acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 567 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
About this 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
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
- Being tested
- Eslicarbazepine acetate, Placebo
- Keywords
- pain herpetic neuralgia
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eslicarbazepine acetateDrug
Also called Zebinix
Scored tablets
PlaceboDrug
oral route
| Study group | Role | What they receive |
|---|---|---|
| ESL 400 mg twice-daily | Experimental | ESL 400 mg twice-daily Receives: Drug: Eslicarbazepine acetate |
| ESL 800 mg once-daily | Experimental | ESL 800 mg once-daily Receives: Drug: Eslicarbazepine acetate |
| ESL 600 mg twice daily | Experimental | ESL 600 mg twice daily Receives: Drug: Eslicarbazepine acetate |
| ESL 1200 mg once daily | Experimental | ESL 1200 mg once daily Receives: Drug: Eslicarbazepine acetate |
| ESL 800 mg twice daily | Experimental | ESL 800 mg twice daily Receives: Drug: Eslicarbazepine acetate |
| placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startNov 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981227
- Sponsor's protocol ID
- BIA-2093-207
- Status last verified
- Oct 2014
- First submitted
- 18 Sep 2009
- Last updated
- 29 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00981227
- Acronym / sponsor ID
- BIA-2093-207
- Conditions
- Postherpetic Neuralgia
- Keywords
- pain herpetic neuralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 3 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with post-herpetic neuralgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ESL 400 mg twice-daily | Experimental | Drug: Eslicarbazepine acetateESL 400 mg twice-daily |
| ESL 800 mg once-daily | Experimental | Drug: Eslicarbazepine acetateESL 800 mg once-daily |
| ESL 600 mg twice daily | Experimental | Drug: Eslicarbazepine acetateESL 600 mg twice daily |
| ESL 1200 mg once daily | Experimental | Drug: Eslicarbazepine acetateESL 1200 mg once daily |
| ESL 800 mg twice daily | Experimental | Drug: Eslicarbazepine acetateESL 800 mg twice daily |
| placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eslicarbazepine acetateAlso: ZebinixScored tablets | Drug | 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 |
| Placebooral route | Drug | placebo |
Primary outcome
Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain
Time frame: baseline and 13 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eslicarbazepine acetate in people with Postherpetic Neuralgia, run by Bial - Portela C S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain (time frame: baseline and 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.