Phase 4
N=2
Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations
Erythromelalgia
Bottom Line
View on ClinicalTrials.gov: NCT02214615 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Carbamazepine Affects Pain in Patients With S241T NaV1.7 IEM Mutation — 3015; 136; 6360; 915 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Carbamazepine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Connecticut Healthcare System
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Carbamazepine Affects Pain in Patients With S241T NaV1.7 IEM Mutation |
3015; 136; 6360; 915 | — |
| SECONDARY Carbamazepine Affects Mean Duration of Pain Episode |
274.1; 45.3; 615; 91.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02214615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.