Clinical Trial: Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: VA Connecticut Healthcare System

Current Primary Outcome:

• Characterize the neural representation of the ongoing pain of IEM using fMRI brain scans to measure blood oxygen level dependent (BOLD) signal [ Time Frame: 3-4 months ]
  7 visits with 5 fMRI scans at set time points during medication and placebo administration
• Pain level in response to CBZ [ Time Frame: 3-4 months ]
  Study the pain levels of specific IEM patients and their brain pain matrix response after acute and chronic treatment with CBZ versus placebo in a double blind cross-over design protocol

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: VA Connecticut Healthcare System

Dates:
Date Received: August 10, 2014
Date Started: April 2014
Date Completion: June 2016
Last Updated: July 13, 2015
Last Verified: July 2015