Efficacy, safety and tolerability of lacosamide in patients with gain-of-function Nav1.7 mutations related small fiber neuropathy: a randomized, double-blind, placebo controlled, crossover trial - MaYa-Nav1.7 study

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月29日

试验速览

Trial is onging in other countries

•Small fiber neuropathy, presence of confirmed abnormality on intra-epidermal nerve fiber density evaluation (IENFD) and/or Quantitative Sensory Testing (QST) and a mutation in the SCN9A gene, confirmed by sequencing.

•-Subjects with predominantly signs of large nerve fiber involvement (muscle weakness, loss of vibration sense, hypo-/-areflexia), clinically significant abnormal nerve conduction studies (NCS).
•-History or presence of illnesses known to cause SFN (excluding diabetes mellitus), including liver, kidney or thyroid dysfunction, monoclonal gammopathy, connective tissue disorders, sarcoidosis, Sjogren syndrome, amyloidosis, Fabry disease, celiac disease, HIV and neurotoxic drugs (e.g., chemotherapy).
•-Subjects taking medications with activity at sodium channels e.g., lamotrigine, carbamazapine, oxcarbazapine, mexiletine, amitriptyline, topical analgesics e.g., lidocaine patches, capsaicin patches and oral/injectable corticosteroids.

发起方

Medisch Universitair Ziekenhuis Maastricht