MedTrace Logo

Safety and Tolerability of Lacosamide in Patients With Gain-of-function Nav1.7 Mutations Related Small Fiber Neuropathy

NCT01911975 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-01-10

No results posted yet for this study

Summary

Lacosamide is a functionalized amino acid with antinociceptive properties in inflammatory and neuropathic pain, and displays a unique mechanism: it enhances slow inactivation of Nav1.3, Nav1.7, and Nav1.8.

Nav1.7 is expressed predominantly in nociceptive and sympathetic neurons. Gain-of-function mutations have been described in Nav1.7 that result in extreme pain disorders such as SCN9A-associated small fiber neuropathy. In the disease states genetically linked to a gain-of-function of Nav1.7, the sodium channel is mutated to increase the sodium influx resulting in a hyperexcitable sensory neuron, and a resultant sensation of pain.

The objective of the study is to determine the efficacy and safety of lacosamide, a sodium channel blocker, in patients with pain due to SCN9A-associated small fiber neuropathy.

Conditions

  • Small Fiber Neuropathy

Interventions

DRUG

Lacosamide

comparison between lacosamide 200mg twice daily and microcrystalline cellulose (placebo) 200mg twice daily.

DRUG

Placebo

comparison between microcrystalline cellulose (placebo) 200mg twice daily and lacosamide 200mg twice daily.

Sponsors & Collaborators

  • Academisch Ziekenhuis Maastricht

    lead OTHER

Principal Investigators

  • Catharina G Faber, MD, PhD · Academisch Ziekenhuis Maastricht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01911975 on ClinicalTrials.gov