This study has been transitioned to CTIS with ID 2024-511008-17-00 check the CTIS register for the current data. To assess whether lacosamide is as efficient in the treatment of chemotherapy-induced neuropathic pain as duloxetine
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective:
To explore the analgesic effect of lacosamide compared to duloxetine in
patients with painful chemotherapy-induced polyneuropathy.
Secondary outcome
Secondary Objective(s):
1. To assess the side effect profile of lacosamide and duloxetine
2. To phenotype patients with painful chemotherapy-induced polyneuropathy using
quantitative sensory testing, conditioned pain modulation, offset analgesia and
cornea confocal microscopy
3. To correlate the CIPN phenotype of patients with the treatment effect of
lacosamide and duloxetine.
Background summary
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. Duloxetine 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.
Study objective
This study has been transitioned to CTIS with ID 2024-511008-17-00 check the CTIS register for the current data.
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, non-inferiority trial
Intervention
Treatment with duloxetine or lacosamide for 8 weeks.
Study burden and risks
See E9 and E9a. Both treatments have been applied in patients for a long time.
We will titrate based on side effects. We think burden and risk are at balance
with possible positive therapeutic effects in this patient population with
neuropathic pain and limited effective treatment options.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
1. Age> 18 years
2. Able to give oral and written informed consent
3. Presence of CIPN grade 1 or higher according to the NCIC-CTC
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 at least 3 months after the last
chemotherapy
Exclusion criteria
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. Heart Rhythm Disorders (including 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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-511008-17-00 |
| EudraCT | EUCTR2020-001285-11-NL |
| CCMO | NL73535.058.20 |