A Randomized, open label, Non-inferiority trial on the efficacy of Lacosamide versus Duloxetine in Patients with Chemotherapy-induced Polyneuropathy – A strategy trial
- Conditions
- Chemotherapy-induced polyneuropathyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-001285-11-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
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 45 or higher
5.Chemotherapy with taxanes, platinums, vincalkinioids or bortezomib in the last 2 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
A potential subject who meets any of the following criteria will be excluded from participation in this study
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
7.Concomittant neuropathy other than chemotherapy-induced
8.Moderate and severe liver enzyme abnormalities
9.Kidney dysfunction (GFR < 30 mL/min)
10.Severe heart failure
11.Any condition that by the judgement of the investigator might interfere with the investigation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method