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Evaluation of the efficacy and safety of lacosamide to duloxetine in the treatment of taxanes- induced peripheral neuropathy

Phase 2
Recruiting
Conditions
Taxane-induced neuropathy.
Registration Number
IRCT20090613002027N21
Lead Sponsor
Mazandaran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

People aged 18 years and older
Patients with taxane-induced peripheral neuropathy
Existence of moderate to severe neuropathic pain with PI-NRS score =4
Normal baseline ECG

Exclusion Criteria

Patients with a history of neurological diseases such as hereditary or acquired neuropathies
Patients with neuropathic pain due to conditions such as post-herpes neuralgia, uncontrolled diabetes with neuropathy, trigeminal neuralgia, spinal cord injury or other neurological diseases, known vitamin B12 deficiency, amyloidosis, neuromuscular diseases and connective tissue diseases
Creatinine clearance less than 30 ml / min
Severe liver failure
History of allergy to lacosamide or duloxetine
History of duloxetine or lacosamide use
Evidence of severe systemic disease
patients with epilepsy
Drugs that interact with the study drugs including tricyclic antidepressants (TCAs), norepinephrine-specific serotonin reuptake inhibitors (SNRIs), and sodium channel blockers in the past three months
Use of monoamine oxidase inhibitors (MAOIs) in the last fourteen days or simultaneously
Drugs that interact with the study drugs including atazanavir, siponimod, carbamazepine, phenobarbital, phenytoin, amiodarone, sotalol, antiarrhythmic drugs that increase QT interval, including class IA and IC, beta-blockers and non-dihydropyridine calcium channel blockers, lidocaine, and mexiletine
Pregnant or lactating women
Dissatisfaction with participating in the study

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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