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Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations

Primary Purpose

Erythromelalgia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Carbamazepine
Placebo
Sponsored by
VA Connecticut Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erythromelalgia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis/symptoms of EM
  • specific NaV1.7 sodium channel mutations (including S241T)

Exclusion Criteria:

  • patients with no identified NaV1.7 mutation

Sites / Locations

  • Yale University
  • VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Carbamazepine

Placebo

Arm Description

Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.

Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.

Outcomes

Primary Outcome Measures

Carbamazepine Affects Pain in Patients With S241T NaV1.7 IEM Mutation

Secondary Outcome Measures

Carbamazepine Affects Mean Duration of Pain Episode

Full Information

First Posted
August 10, 2014
Last Updated
May 8, 2017
Sponsor
VA Connecticut Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT02214615
Brief Title
Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations
Official Title
Pilot Study on the Response of Inherited Erythromelalgia Patients With NaV1.7 Mutations to Carbamazepine: Clinical Imaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythromelalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbamazepine
Arm Type
Active Comparator
Arm Description
Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.
Intervention Type
Drug
Intervention Name(s)
Carbamazepine
Other Intervention Name(s)
Tegretol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Carbamazepine Affects Pain in Patients With S241T NaV1.7 IEM Mutation
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Carbamazepine Affects Mean Duration of Pain Episode
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis/symptoms of EM specific NaV1.7 sodium channel mutations (including S241T) Exclusion Criteria: patients with no identified NaV1.7 mutation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Waxman, MD, PhD
Organizational Affiliation
VAMC West Haven and Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

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Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations

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