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

NCT00980746 | Completed Phase 2 Results

• 2 other identifiers: BIA-2093-206EudraCT 2007-002461-12
• Study Type: interventional
• Target: 557
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Keywords

pain diabetes neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  17 weeks

Study Arms (6)

ESL 400 mg BID

EXPERIMENTAL

ESL 400 mg twice daily (BID)

Drug: Eslicarbazepine acetate

ESL 800 mg QD

EXPERIMENTAL

ESL 800 mg once-daily (QD)

Drug: Eslicarbazepine acetate

ESL 600 mg BID

EXPERIMENTAL

Eslicarbazepine 600 mg twice daily

Drug: Eslicarbazepine acetate

ESL 1200 mg QD

EXPERIMENTAL

Eslicarbazepine acetate 1200 mg once daily

Drug: Eslicarbazepine acetate

ESL 800 mg BID

EXPERIMENTAL

Eslicarbazepine acetate 800 mg twice daily

Drug: Eslicarbazepine acetate

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Eslicarbazepine acetate DRUG

Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.

Also known as: Zebinix

ESL 1200 mg QD; ESL 400 mg BID; ESL 600 mg BID; ESL 800 mg BID; ESL 800 mg QD

Placebo DRUG

oral route

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Head of Clinical Research Section
• Organization: BIAL - Portela & Ca, SA

clinical.trials@bial.com

351 22 986 6100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 21, 2009
• Study Start: November 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: June 22, 2016
• Results First Posted: May 22, 2013

Record last verified: 2016-05