Painful Diabetic NeuropathyPhase 2NCT00980746

Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy

A Phase 2 study testing Eslicarbazepine acetate in people with Painful Diabetic Neuropathy, run by Bial - Portela C S.A..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy. 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 557 participants
Where: No sites listed yet
Study dates: Nov 2007to Nov 2008
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
Diagnosis of diabetes mellitus Type 1 or 2
Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
Stable glycemic control: (total glycated haemoglobin [HbA1c] level ≤ 11% at screening)
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 Numeric rating pain scale (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 diabetic origin
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Peripheral vascular disease with a history of amputation, except amputation of toes
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 normal, white blood cell count (WBC) <2,500 cells/mm3)

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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 clinically 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 2 093) as Therapy for Patients With Painful Diabetic Neuropathy: 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 painful diabetic neuropathy.

Conditions: Painful Diabetic Neuropathy
Being tested: Eslicarbazepine acetate, Placebo
Keywords: pain diabetes neuropathy
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 acetateDrug
Also called Zebinix
Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
PlaceboDrug
oral route

Study groups in NCT00980746
Study group	Role	What they receive
ESL 400 mg BID	Experimental	ESL 400 mg twice daily (BID) Receives: Drug: Eslicarbazepine acetate
ESL 800 mg QD	Experimental	ESL 800 mg once-daily (QD) Receives: Drug: Eslicarbazepine acetate
ESL 600 mg BID	Experimental	Eslicarbazepine 600 mg twice daily Receives: Drug: Eslicarbazepine acetate
ESL 1200 mg QD	Experimental	Eslicarbazepine acetate 1200 mg once daily Receives: Drug: Eslicarbazepine acetate
ESL 800 mg BID	Experimental	Eslicarbazepine acetate 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 From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain
Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period.
Measured: 17 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Nov 2008

First posted21 Sep 2009 (estimated)
Study startNov 2007
Primary completionNov 2008
Study completionNov 2008

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 557 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00980746
Sponsor's protocol ID: BIA-2093-206
Other IDs: EudraCT 2007-002461-12
Status last verified: May 2016
First submitted: 18 Sep 2009
Last updated: 22 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
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Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
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Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
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Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
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All Painful Diabetic Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Eslicarbazepine Acetate (BIA 2 093) as Therapy for Patients With Painful Diabetic Neuropathy: a Double-blind, Double-dummy, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial
ClinicalTrials.gov ID: NCT00980746
Acronym / sponsor ID: BIA-2093-206
Conditions: Painful Diabetic Neuropathy
Keywords: pain diabetes neuropathy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 557 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 21 Sep 2009 (estimated)
Results: Posted 22 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 painful diabetic neuropathy.

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 BID	Experimental	Drug: Eslicarbazepine acetateESL 400 mg twice daily (BID)
ESL 800 mg QD	Experimental	Drug: Eslicarbazepine acetateESL 800 mg once-daily (QD)
ESL 600 mg BID	Experimental	Drug: Eslicarbazepine acetateEslicarbazepine 600 mg twice daily
ESL 1200 mg QD	Experimental	Drug: Eslicarbazepine acetateEslicarbazepine acetate 1200 mg once daily
ESL 800 mg BID	Experimental	Drug: Eslicarbazepine acetateEslicarbazepine acetate 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 (8 listed)

Written informed consent to participate in the study
Men and women aged 18 years or older
Diagnosis of diabetes mellitus Type 1 or 2
Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
Stable glycemic control: (total glycated haemoglobin [HbA1c] level ≤ 11% at screening)

Key exclusion criteria (13 listed)

Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
Significant or unstable medical or psychiatric disorders
Drug or alcohol abuse in the preceding 2 years
Peripheral vascular disease with a history of amputation, except amputation of toes
Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening

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: ZebinixEslicarbazepine acetate tablets, scored to allow dose titration during the titration period.	Drug	ESL 1200 mg QD, ESL 400 mg BID, ESL 600 mg BID, ESL 800 mg BID, ESL 800 mg QD
Placebooral route	Drug	Placebo

Primary outcome

Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain
Time frame: 17 weeks
Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period.

Results and safety

Results posted to the registry on 22 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ESL 1200 mg QD	85	58
ESL 400 mg BD	89	67
ESL 600 mg BID	95	75
ESL 800 mg BID	100	64
ESL 800 mg QD	92	75
Placebo	96	78

Primary outcome: Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain

Time frame: 17 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	ESL 1200 mg QD n = 85	ESL 400 mg BD n = 89	ESL 600 mg BID n = 95	ESL 800 mg BID n = 100	ESL 800 mg QD n = 92	Placebo n = 96
Value	-1.7546 (0.2352)	-2.2865 (0.2325)	-1.6746 (0.2312)	-1.8353 (0.2260)	-1.9829 (0.2328)	-1.5801 (0.2311)

Adverse events

Time frame: All Treatment-emergent adverse event (TEAEs), i.e. those Adverse events (AEs) starting after the first dose intake until 2 days after the last dose,have been summarized. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ESL 1200 mg QD	7 of 85 (8.2%)	11 of 85 (12.9%)	Not reported
ESL 400 mg BD	3 of 89 (3.4%)	0 of 89 (0%)	Not reported
ESL 600 mg BID	0 of 95 (0%)	23 of 95 (24.2%)	Not reported
ESL 800 mg BID	4 of 100 (4%)	35 of 100 (35%)	Not reported
ESL 800 mg QD	1 of 92 (1.1%)	0 of 92 (0%)	Not reported
Placebo	0 of 96 (0%)	6 of 96 (6.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Painful Diabetic Neuropathy

Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
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Active, not recruitingPhase 3
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Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
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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 Painful Diabetic Neuropathy, 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 8 inclusion and 13 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 22 Jun 2016. 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 22 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 From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain (time frame: 17 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00980746.

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 22 Jun 2016.