Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations

Erythromelalgia Clinical Trial

Official title: Pilot Study on the Response of Inherited Erythromelalgia Patients With NaV1.7 Mutations to Carbamazepine: Clinical Imaging Study

Status Enrolling by invitation

Clinical Trial Summary

This research study is designed to investigate brain response using fMRI scan, and behavioral responses, to treatment with the drug carbamazepine (CBZ) in patients with the painful sodium channelopathy inherited Erythromelalgia (IEM). This study is designed to identify the central nervous system (CNS) regions that are activated during ongoing or evoked pain attacks, and the altered CNS response to CBZ treatment. This will advance our understanding of how IEM affects the brain. We also hope to validate a pharmacogenic approach to the study of IEM by use of an FDA approved drug. We hope, but cannot be sure, that subjects will directly benefit from this study.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erythromelalgia

• NCT number: NCT02214615
• Study type: Interventional
• Source: VA Connecticut Healthcare System
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: April 2014
• Completion date: June 2016