Overview
Sponsor-declared trial summary
chemotherapy-induced neuropathic pain
To explore the analgesic effect of lacosamide compared to duloxetine in patients with painful chemotherapy-induced polyneuropathy
Key facts
- Sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- completed 3 Mar 2026
- Decision date (initial)
- 2024-07-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511008-17-00
- EudraCT number
- 2020-001285-11
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To explore the analgesic effect of lacosamide compared to duloxetine in patients with painful chemotherapy-induced polyneuropathy
Secondary objectives 3
- 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.
Conditions and MedDRA coding
chemotherapy-induced neuropathic pain
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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 14
- Allergy to the study medication
- 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
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pain intensity score during the last 4 weeks of treatment
Secondary endpoints 2
- Patient satisfaction of treatment
- Side effect profile
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cymbalta 30 mg hard gastro-resistant capsules
PRD2500239 · Product
- Active substance
- Duloxetine
- Pharmaceutical form
- GASTRO-RESISTANT CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- N06AX21 — -
- Marketing authorisation
- EU/1/04/296/009
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Vimpat 50 mg film-coated tablets
PRD331912 · Product
- Active substance
- Lacosamide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- N03AX18 — -
- Marketing authorisation
- EU/1/08/470/001
- MA holder
- UCB PHARMA S.A. (ANDERL BE)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leids Universitair Medisch Centrum (LUMC)
- Sponsor organisation
- Leids Universitair Medisch Centrum (LUMC)
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Marieke Niesters
Public contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Marieke Niesters
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 110 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2024-511008-17-00 | 3.0 |
| Recruitment arrangements (for publication) | K1 recruitement arrangements Blank document | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF form | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC duloxetine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Lacosamide | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-17 | Netherlands | Acceptable with conditions 2024-07-29
|
2024-07-29 |