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Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214615
Recruitment Status : Completed
First Posted : August 12, 2014
Results First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
VA Connecticut Healthcare System

Tracking Information
First Submitted Date  ICMJE August 10, 2014
First Posted Date  ICMJE August 12, 2014
Results First Submitted Date  ICMJE June 15, 2016
Results First Posted Date  ICMJE June 6, 2017
Last Update Posted Date June 6, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
Carbamazepine Affects Pain in Patients With S241T NaV1.7 IEM Mutation [ Time Frame: 15 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
Carbamazepine Affects Mean Duration of Pain Episode [ Time Frame: 15 days ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Erythromelalgia
Intervention  ICMJE
  • 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.

    Other Name: Tegretol
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Carbamazepine
    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.
    Intervention: Drug: Carbamazepine
  • Placebo Comparator: Placebo
    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: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2014)
2
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with no identified NaV1.7 mutation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02214615
Other Study ID Numbers  ICMJE SW0023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Connecticut Healthcare System
Study Sponsor  ICMJE VA Connecticut Healthcare System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Waxman, MD, PhD VAMC West Haven and Yale University
PRS Account VA Connecticut Healthcare System
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP