We hypothesize that lacosamide will reduce pain equivalent to duloxetine.
ID
Bron
Verkorte titel
Aandoening
Chemotherapy induced polyneuropathy (CIPN)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To explore the analgesic effect of lacosamide compared to duloxetine in patients with painful chemotherapy-induced polyneuropathy.
Achtergrond van het onderzoek
Rationale: Lacosamide is an anti-epileptic drug which has recently gained interest for the treatment of neuropathic pain. Animal data and data from case reports indicate that lacosamide may be effective for the treatment of chemotherapy-induced neuropathic pain. In the current randomized, open label, equivalence study the efficacy of lacosamide is compared to duloxetine which is currently the most efficient treatment for chemotherapy induced neuropathic pain according to literature. More proven effective drugs expand the number of treatment options for patients suffering from neuropathic pain as each drug has a specific side effect profile.
Objective: To assess whether lacosamide is as efficient in the treatment of chemotherapy-induced neuropathic pain as duloxetine.
Study design: This is a randomized, open label, equivalence trial.
Study population: Patients with painful chemotherapy-induced polyneuropathy.
Intervention (if applicable): Patients are randomized to either receive duloxetine titrated to an effective dose with a maximum of 120 mg or lacosamide titrated to an effective dose with a maximum of 300 mg twice daily.
Main study parameters/endpoints: The primary outcome is pain relief. Furthermore side effect profile will be assessed. Patients will be subjected to a variety of tests to phenotype their polyneuropathy. Tests performed include a quantitative sensory testing battery, conditioned pain modulation, offset analgesia and cornea confocal microscopy. Phenotyping patients may give insight in differential treatment effects within the population of CIPN patients.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: At the doses applied in the current study and the close monitoring by the study team we foresee just limited concerns for major issues. Both drugs are registered drugs for pain, depression and epilepsy and are already used for a long time in patients. We will closely monitor the patients and assess whether treatment should be modified in case of side effects. Dosages will be titrated based on efficacy and side effect profile.
Doel van het onderzoek
We hypothesize that lacosamide will reduce pain equivalent to duloxetine.
Onderzoeksopzet
Patients visit our facility for QST phenotyping on two occasions. The 8 week treatment will be managed via weekly telephone consultations.
Onderzoeksproduct en/of interventie
Lacosamide vs Duloxetine
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9174 |
| Ander register | METC LDD : P20.059 |