Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain

Status Terminated

Clinical 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.

Clinical Trial 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

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01129960
Study type	Interventional
Source	Bial - Portela C S.A.
Contact
Status	Terminated
Phase	Phase 3
Start date	November 2010
Completion date	April 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04699734` - Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy	N/A
Recruiting	`NCT05480228` - EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA	Phase 2
Recruiting	`NCT05476276` - EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy	Phase 2
Unknown status	`NCT01125215` - Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy	Phase 2/Phase 3
Not yet recruiting	`NCT05937984` - Treatment for Painful Diabetic Neuropathy	N/A
Recruiting	`NCT05080530` - Vitamin D and Painful Diabetic Neuropathy	N/A
Completed	`NCT04005287` - A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy	Phase 2
Recruiting	`NCT03331614` - An Evaluation of an SCCD on the Symptomatology of Painful DPN	N/A
Recruiting	`NCT03700528` - The Development of Contextual Cognitive Behavioural Approach to PDN	N/A
Recruiting	`NCT04689971` - The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient	Phase 2/Phase 3
Recruiting	`NCT04689958` - The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient	Phase 2/Phase 3
Recruiting	`NCT04689984` - The Benefits of Astaxanthin as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient	Phase 2/Phase 3
Completed	`NCT03749642` - Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy	Phase 2
Not yet recruiting	`NCT04087941` - Efficacy and Safety of VM202 in Painful Diabetic Peripheral Neuropathy -The HOPES Trial	Phase 2
Terminated	`NCT01056315` - A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y	Phase 2
Completed	`NCT00980746` - Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy	Phase 2
Completed	`NCT04786340` - A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy	Phase 2
Completed	`NCT03769675` - Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation	N/A
Completed	`NCT03755934` - Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy	Phase 2
Not yet recruiting	`NCT05118217` - Microvascular Dysfunction in Diabetic Peripheral Neuropathy