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A Randomized, open label, Non-inferiority trial on the efficacy of Lacosamide versus Duloxetine in Patients with Chemotherapy-induced Polyneuropathy - A strategy trial
EU CTIS ID: 2024-511008-17-00
What this study is testing
To explore the analgesic effect of lacosamide compared to duloxetine in patients with painful chemotherapy-induced polyneuropathy
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.