Trials / Terminated

TerminatedNCT03777956

The Effect of Lacosamide in Peripheral Neuropathic Pain

The Effect of Lacosamide in Peripheral Neuropathic Pain: a Randomized, Double-blind, Placebo Controlled, Phenotype-stratified Study

Status: Terminated
Phase: Phase 2
Study type: Interventional
Enrollment: 63 (actual)

Sponsor: Danish Pain Research Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Detailed description

The main purpose of this study is to compare the change in pain intensity during treatment with a sodium-channel blocker (lacosamide) in patients with peripheral neuropathic pain with and without the irritable nociceptor phenotype. As this is a mechanistic study, the main purpose is to compare the change in pain intensity in patients who receive an expected sufficiently effective dose of lacosamide. As supportive evidence for a drug-specific predictive biomarker, the purpose is also to compare the change in pain intensity during lacosamide vs. placebo for the two phenotypes. We hypothesize that the sodium-channel blocker lacosamide will be more effective in patients with the irritable nociceptor than those without the non-irritable nociceptor phenotype, and that lacosamide is more effective than placebo in patients with the irritable nociceptor phenotype.

Conditions

Interventions

Type	Name	Description
DRUG	Lacosamide	Lacosamide (50 mg) and identical placebo are given as capsules and taken orally twice a day, up to 200 mg b.i.d.
DRUG	Placebo	Identical placebo are given as capsules and taken orally twice a day.

Timeline

Start date: 2019-01-15
Primary completion: 2022-06-03
Completion: 2022-06-03
First posted: 2018-12-19
Last updated: 2023-02-16

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT03777956. Inclusion in this directory is not an endorsement.