Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vertex Pharmaceuticals Incorporated
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight \>50 kg
Diagnosis of small fiber neuropathy, as per European Federation Neurological Societies (EFNS)/American Academy of Neurology (AAN) guidelines, with pain for at least 3 months prior to screening
Reduction below the 5th percentile of sex and age-adjusted normal values in epidermal nerve fiber density on punch skin biopsy at the distal site of the leg performed at screening
Normal nerve conduction studies (NCS), including presence of sural response.
Average NRS score between ≥4 and ≤9 reported in the daily diary on Days -7 through -1
You may not be if
History in the past 10 years of malignancy except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
History of connective tissue disorders, sarcoidosis, Sjögren's syndrome, amyloidosis, Fabry's disease, celiac disease, lyme disease, autoimmune disorders
A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
Current clinically significant liver or kidney dysfunction
Current uncontrolled thyroid dysfunction
A diagnosis of diabetes, HbA1C ≥8% at screening
History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
Concomitant severe pain conditions which may impair self-assessment of pain due to small fiber neuropathy
Clareo Health | A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy
