A Randomized, open label, Non-inferiority trial on the efficacy of Lacosamide versus Duloxetine in Patients with Chemotherapy-induced Polyneuropathy - A strategy trial

Phase 1

Conditions: chemotherapy-induced neuropathic pain
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: CTIS2024-511008-17-00

Lead Sponsor: eids Universitair Medisch Centrum (LUMC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

Age> 18 years, Able to give oral and written informed consent, Indications of small- or large fiber neuropathy with quantitative sensory testing (compared to healthy population)., Pain score of 4 or higher, Chemotherapy with taxanes, platinums, vicalkiniods or bortezomib in the past, Presence of symptoms of neuropathic pain at least 3 months after the last chemotherapy

Exclusion Criteria

Allergy to the study medication, Kidney dysfunction (GFR < 30 mL/min), Severe heart failure (e.g. as a result of infarction or a structural heart defect), Heart Rhythm Disorders (including 2nd or 3rd degree atrioventricular (AV) block and sodium channelopathies., Systolic blood pressure above 180mm Hg with current antihypertensive medications (according to screening measurement), Any condition that by the judgement of the investigator might interfere with the investigation, Epilepsy, History of illicit drug or alcohol abuse, History of psychosis, Pregnancy or lactation, Use of anti-epileptic or anti-depressant medication (in particular MAO inhibitors), Use of CYP1a2 inhibitors (e.g. fluvoxamine, fluocinolone, cimetidine), Concomitant neuropathy other than chemotherapy-induced, Moderate and severe liver enzyme abnormalities

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To explore the analgesic effect of lacosamide compared to duloxetine in patients with painful chemotherapy-induced polyneuropathy;Secondary Objective: 1. To assess the side effect profile of lacosamide and dulexetine., 2. To phenotype patients with painful chemotherapy-induced polyneuropathy using quantitative sensory testing, conditioned pain modulation, offset anagesia and cornea confocal microscopy., 3. To correlate the CIPN phenotype of patients with the treatment effect of lacosamide and duloxetine.;Primary end point(s): Pain intensity score during the last 4 weeks of treatment

Secondary Outcome Measures