The Effect of Lacosamide in Peripheral Neuropathic Pain

Exclusion Criteria

• •1. Other causes of pain in the same area, or other concomitant pain that cannot be distinguished from the neuropathic pain
• •2. Patient who cannot cooperate or are unable to complete the project and patients who do not speak Danish.
• •3. Known and current cardiac conduction disturbance (2⁰ or 3⁰ atrioventricular (AV) block, prolonged QTc interval \> 450 ms, heart rate \<50 or \>110 bpm, a QRS interval \>120ms (ECG required)), significant cardiac, renal or liver disease or other severe illness. In patients treated with pregabalin also PQ interval \> 0,2s and cardiac disease. Sitting diastolic blood pressure below 50 mmHg or above 105 mmHg.
• •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. Woman of childbearing potential, unless they use and acceptable effective contraception measure as defined in the Clinical Trials Facilitation Group (CTFG) during the study and at least 2 weeks after, or if their male partner is vasectomized and their sole partners. Negative pregnancy test is required.
• •7. Known allergy to lacosamide or excipients.
• •8. Concomitant pain treatment with tricyclic antidepressants, topical analgesics (lidocaine, capsaicin), lamotrigine, oxcarbazepine, cannabinoids or strong opioids that cannot be discontinued. Other treatment 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.
• •10. Patients inappropriate for placebo
• •11. Planned surgery
• •12. Use of sodium channel blockers within at least five half-lives and investigational drugs within 30 days.
• •13. Patients on controlled sodium diet, unless the amount of sodium in the capsules is acceptable for their diet.
• •14. The score "yes" on item 4 or item 5 of the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS), if the ideation occurred in the past 6 months, or "yes on any item of the Suicidal Behaviour section, except for the "Non-suicidal Self Injurious Behaviour" if this behaviour occurred in the past 2 years.