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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02214615
• Other study ID #: SW0023
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: August 10, 2014
• Last updated: July 13, 2015
• Start date: April 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2015
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosis/symptoms of EM

• specific NaV1.7 sodium channel mutations (including S241T)

Exclusion Criteria:

• patients with no identified NaV1.7 mutation

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

Intervention

Drug:
• Carbamazepine
Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day. Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days.
• Placebo

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the neural representation of the ongoing pain of IEM using fMRI brain scans to measure blood oxygen level dependent (BOLD) signal	7 visits with 5 fMRI scans at set time points during medication and placebo administration	3-4 months	No
Primary	Pain level in response to CBZ	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	3-4 months	No