AX Trial
- Conditions
- Chemotherapy induced polyneuropathy (CIPN)
- Registration Number
- NL-OMON21156
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 110
1. Age> 18 years
2. Able to give oral and written informed consent
3. Indications of small- or large fiber neuropathy with quantitative sensory testing (compared to healthy population)
4. Pain score of 4 or higher
5. Chemotherapy with taxanes, platinums, vincalkinioids or bortezomib in the past
6. Presence of symptoms of neuropathic pain for at least 6 months after the last chemotherapy
1. Allergy to the study medication
2. Epilepsy
3. History of illicit drug or alcohol abuse
4. History of psychosis
5. Pregnancy or lactation
6. Use of anti-epileptic or anti-depressant medication (in particular MAO inhibitors)
7. Use of CYP1a2 inhibitors (e.g. fluvoxamine, fluocinolone, cimetidine)
8. Concomitant neuropathy other than chemotherapy-induced
9. Moderate and severe liver enzyme abnormalities
10. Kidney dysfunction (GFR < 30 mL/min)
11. Severe heart failure (e.g. as a result of infarction or a structural heart defect)
12. 2nd or 3rd degree atrioventricular (AV) block and sodium channelopathies.
13. Systolic blood pressure above 180mm Hg with current antihypertensive medications (according to screening measurement)
14. Any condition that by the judgement of the investigator might interfere with the investigation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To explore the analgesic effect of lacosamide compared to duloxetine in patients with painful chemotherapy-induced polyneuropathy.
- Secondary Outcome Measures
Name Time Method 1. To assess the side effect profile of lacosamide and duloxetine<br>2. To phenotype patients with painful chemotherapy-induced polyneuropathy using quantitative sensory testing, conditioned pain modulation, offset analgesia and cornea confocal microscopy<br>3. To correlate the CIPN phenotype of patients with the treatment effect of lacosamide and duloxetine.