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

Phase 3

Completed

Conditions: peripheral nerve disorder
Small fiber neuropathy
10034606

Registration Number: NL-OMON41621

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

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.

Exclusion Criteria

-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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Endpoints<br /><br>Primary Endpoint<br /><br>* Change from baseline in the average pain score as measured using a Pain<br /><br>Intensity Numerical Rating Scale [PI-NRS], an 11-point numerical scale where 0<br /><br>= no pain and 10 = worst possible pain.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints<br /><br>* Maximum Pain Score on the PI-NRS.<br /><br>* Neuropathic Pain Scale (NPS).<br /><br>* Daily Sleep Interference Scale (DSIS).<br /><br>* Patient Global Impression of Change (PGIC).<br /><br>* Small Fiber Neuropathy Symptoms Inventory questionnaire (SFN-SIQ).<br /><br>* Generic short-form SF-36 health survey (SF-36).<br /><br>* Adverse Events, Laboratory Safety Tests (Hematology, Clinical Chemistry,<br /><br>Urinalysis), Blood Pressure, Pulse Rate, ECG</p><br>