The effect of lacosamide in peripheral neuropathic pain: a randomized, double-blind, placebo-controlled, stratified beased on clinical characteristics

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 108

Inclusion Criteria

1. Age = 18 years.
2. Probable or definite peripheral neuropathic pain for at least 3 months.
3. Average pain intensity of at least 4 and not above 9 on a 0-10 NRS during the 7-day baseline week.
3. Written informed consent.

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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

1. Other causes of pain in the same area or other concomitant pain that cannot be distinguished from the neuropathic pain.
2. Patients who cannot cooperate or are unable to complete the project and patients who do not speak Danish.
3. Known and current cardiac conduction disturbance (2nd or 3rd atrioventricular block, prolonged QTc interval >450 ms, heart rate <50 or >110 bpm, a QRS interval > 120 ms (12-lead ECG required)), significant cardiac disease (e.g. history of myocardial infarction, heart failure, or cardiovascular syncope), significant renal disease or liver disease or other severe illness (sodium, potassium, creatinine, eGRF, ALAT, basic phosphatase, LDH and for patients with diabetes: HA1c will be taken unless they are available within the past 3 months; the cut-off values for inclusion will be at the discretion of the investigator). Sitting diastolic blood pressure below 50 mm Hg or above 105 mm Hg. In patients treated with pregabalin also PQ interval >0.2s and cardiac disease.
4. Major depressive episode within 6 months, recurrent depressive disorder or other significant psychiatric disease, alcohol, illicit drug or drug abuse.
5. Pregnancy or lactation.
6. Women of child-bearing potential unless they use an acceptable effective contraception measure during the study and at least 2 weeks after or their male partner is vasectomized and their sole partner. Acceptable effective contraception is defined in the Clinical Trials Facilitation Group (CTFG) http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) and include intrauterine device or hormone-releasing system or hormonal contraception or total abstinence when this reflects their usual lifestyle or female sterilization (bilateral oophorectomy or total hysterectomy at least 6 weeks before). They should also have a negative pregnancy test.
7. Known allergy to lacosamide or excipients.
8. Concomitant pain treatment with tricyclic antidepressants (can be associated with PR prolongation), topical analgesics (lidocaine, capsaicin), cannabinoids, or strong opioids that cannot be discontinued. Other concomitant treatments for neuropathic pain are allowed in a stable dose (from 14 days before randomization to completion of the trial), if they cannot be tapered off completely.
9. Concomitant treatment with products known to be associated with PQ (PR) prolongation other than pregabalin.
9. Patients inappropriate for placebo.
10. Planned surgery.
11. Use of sodium channel blockers within at least five half-lives and investigational drugs within 30 days.
12. Patients on a controlled sodium diet, unless the amount of sodium in the capsules is acceptable for their diet.
13. The score yes” on item 4 or item 5 of the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS), if this ideation occurred in the past 6 months, or yes” on any item of the Suicidal Behavior section, except for the Non-Suicidal Self-Injurious Behavior” (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the change in pain intensity during treatment with a sodium-channel blocker (lacosamide) in patients with peripheral neuropathic pain with and without the irritable nociceptor phenotype;Secondary Objective: To compare the change in Pain intensity during lacosamide vs placebo the the two phenotypes;Primary end point(s): The difference in the mean value of the patient's daily ratings of average pain intensity in the baseline week and the last week during treatment as experienced during the past 24 hours rated on a 0-10 point numeric rating scale (NRS; 0 = no pain, 10 = worst possible pain). ;Timepoint(s) of evaluation of this end point: Last week of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Pain relief: complete, good, moderate, mild, none, worse <br>•Use of escape medication (paracetamol)<br>;Timepoint(s) of evaluation of this end point: For Pain relief: End of treatment<br>For Escape medication: During treatment

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