Painful Diabetic NeuropathyPhase 3NCT01129960
Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain
A Phase 3 study testing Eslicarbazepine acetate (BIA 2-093) in people with Painful Diabetic Neuropathy, run by Bial - Portela C S.A. at 1 site in Portugal.
Trial summary
The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate (ESL) as therapy in subjects with Diabetic Neuropathic Pain (DNP) over a 15 week treatment phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- Eslicarbazepine acetate (BIA 2-093)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 1 sitePortugal
- Study dates
- Nov 2010to Apr 2012
- Phase
- Phase 3
- 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
- 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.
- Diagnosis of Type 1 or Type 2 diabetes mellitus.
- Pain due to bilateral peripheral polyneuropathy caused by Type 1 or Type 2 diabetes mellitus.
- Have stable glycemic control, as assessed by the investigator, and have glycosylated hemoglobin proportion of less or equal than 11% before randomization.
- A mean score between 4.0 and 9.0, inclusive, on the 24 hour average pain intensity assessment and Visit 3 (ie, 5 of 7 days, 6 of 8 days, 7 of 9 days, or 7 of 10 days).
- Compliance with patient diary completion.
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- If not used to treat DNP, 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.
Who cannot join
- Historical exposure to drugs known to cause neuropathy.
- Significant skin lesions (active infection, ulcer, etc).
- Peripheral vascular disease with a history of amputation, except amputation of toes.
- 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 disorders.
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- Serious or unstable disease that could compromise participation 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 treatment for DNP.
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
BIAL - Portela & Cª, S.A.
S. Mamede Do Coronado, S. Mamede Do Coronado, 4045-457
About this study
Official title: A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Diabetic Neuropathic Pain
The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate (ESL) as therapy in subjects with Diabetic Neuropathic Pain (DNP) over a 15 week treatment phase.
Read the detailed description
Diabetic neuropathic pain (DNP) is one of the most common complications of diabetes mellitus. It currently affects about 1% of the population but its prevalence is expected to increase in coming years (European Medicines Agency 2007) in step with the increase in diabetes mellitus prevalence, which is expected to affect 220 million people by 2010
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 diabetic neuropathic pain.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- Eslicarbazepine acetate (BIA 2-093), Placebo
- Keywords
- Diabetic Neuropathic Pain
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eslicarbazepine acetate (BIA 2-093)Drug
Also called Exalief, Zebinix, BIA 2-093, ESL
Tablets will be used.
PlaceboDrug
Tablets will be used.
| Study group | Role | What they receive |
|---|---|---|
| Eslicarbazepine acetate 800 mg once daily (QD) | Experimental | Not described Receives: Drug: Eslicarbazepine acetate (BIA 2-093) |
| Eslicarbazepine acetate 1200 mg QD | Experimental | Not described Receives: Drug: Eslicarbazepine acetate (BIA 2-093) |
| Eslicarbazepine acetate 1600 mg QD | Experimental | Not described Receives: Drug: Eslicarbazepine acetate (BIA 2-093) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Endpoint in Mean Pain
Study was prematurely halted. The efficacy analysis was restricted to the primary efficacy variable in the interim analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (31st October 2011), was the basis for the efficacy analysis; patients with less than 20 days of study medication were excluded from the analysis, except those with early discontinuation. 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]
Measured: baseline up to endpoint 15 weeks (3-week titration phase and 12-week treatment maintenance phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionApr 2012
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 Painful Diabetic NeuropathyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 332 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
- NCT01129960
- Sponsor's protocol ID
- BIA-2093-307
- Other IDs
- 2010-019100-23
- Status last verified
- Jul 2014
- First submitted
- 3 May 2010
- Last updated
- 18 Jul 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 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Diabetic Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01129960
- Acronym / sponsor ID
- BIA-2093-307
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- Diabetic Neuropathic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 25 May 2010 (estimated)
- Results
- Posted 18 Jul 2014
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 this study is to assess the efficacy of Eslicarbazepine acetate (ESL) as therapy in subjects with Diabetic Neuropathic Pain (DNP) over a 15 week treatment phase.
Detailed description
Diabetic neuropathic pain (DNP) is one of the most common complications of diabetes mellitus. It currently affects about 1% of the population but its prevalence is expected to increase in coming years (European Medicines Agency 2007) in step with the increase in diabetes mellitus prevalence, which is expected to affect 220 million people by 2010
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 diabetic neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eslicarbazepine acetate 800 mg once daily (QD) | Experimental | Drug: Eslicarbazepine acetate (BIA 2-093) |
| Eslicarbazepine acetate 1200 mg QD | Experimental | Drug: Eslicarbazepine acetate (BIA 2-093) |
| Eslicarbazepine acetate 1600 mg QD | Experimental | Drug: Eslicarbazepine acetate (BIA 2-093) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Diagnosis of Type 1 or Type 2 diabetes mellitus.
- Pain due to bilateral peripheral polyneuropathy caused by Type 1 or Type 2 diabetes mellitus.
- Have stable glycemic control, as assessed by the investigator, and have glycosylated hemoglobin proportion of less or equal than 11% before randomization.
- A mean score between 4.0 and 9.0, inclusive, on the 24 hour average pain intensity assessment and Visit 3 (ie, 5 of 7 days, 6 of 8 days, 7 of 9 days, or 7 of 10 days).
Key exclusion criteria (18 listed)
- Historical exposure to drugs known to cause neuropathy.
- Significant skin lesions (active infection, ulcer, etc).
- Peripheral vascular disease with a history of amputation, except amputation of toes.
- 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.
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 acetate (BIA 2-093)Also: Exalief, Zebinix, BIA 2-093, ESLTablets will be used. | Drug | Eslicarbazepine acetate 1200 mg QD, Eslicarbazepine acetate 1600 mg QD, Eslicarbazepine acetate 800 mg once daily (QD) |
| PlaceboTablets will be used. | Drug | Placebo |
Primary outcome
Change From Baseline to Endpoint in Mean Pain
Time frame: baseline up to endpoint 15 weeks (3-week titration phase and 12-week treatment maintenance phase)
Study was prematurely halted. The efficacy analysis was restricted to the primary efficacy variable in the interim analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (31st October 2011), was the basis for the efficacy analysis; patients with less than 20 days of study medication were excluded from the analysis, except those with early discontinuation. 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]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eslicarbazepine acetate (BIA 2-093) in people with Painful Diabetic Neuropathy, run by Bial - Portela C S.A. at 1 site in Portugal.
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 9 inclusion and 18 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: stopped early, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Jul 2014). 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 From Baseline to Endpoint in Mean Pain (time frame: baseline up to endpoint 15 weeks (3-week titration phase and 12-week treatment maintenance phase)). 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 18 Jul 2014.