Active clinical trials for "Small Fiber Neuropathy"

Small fibre neuropathy (SFN) is a disorder in which selectively thinly myelinated and unmyelinated nerve fibres are involved. SFN can cause severe and chronic symptoms such as burning pain in the extremities in combination with autonomic symptoms. So far, the results of symptomatic SFN treatment have been rather disappointing, despite the fact that new agents have been developed. This study is a pilot study to investigate whether Spinal Cord Stimulation (SCS) combined with best (drug) treatment as usual (TAU) leads to clinically significant pain relief in patients suffering from pain in the lower limbs due to SFN, defined as ≥30% pain reduction on a mean NRS during daytime, and/or ≥30% pain reduction on a mean NRS during night-time, and/or at least much improved or very much improved, on the Patient Global Impression of Change (PGIC) for pain and sleep.

The study aims to compare different methods to assess thermal detection ability in diabetic patients, as a way to monitor and diagnose neurological complications of diabetes mellitus.

The aim of work is to study the clinical, electrodiagnostic and neurosonographic characteristics of diabetic patients with small fiber neuropathy in the Egyptian population, and to evaluate both the diagnostic and the prognostic impact of the studied factors on the neuropathy severity and quality of life.

The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or associated with diabetes mellitus. A secondary endpoint that relates to the primary objective is the change from Randomization to Week 12 of the double-blind period in mean average daily pain score. The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient global impression, use of rescue medication, and SFN symptoms in participants treated with BIIB074; to investigate the safety and tolerability of BIIB074 in participants with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.

Idiopathic Small Fiber Neuropathy (called SFN for short), is a condition where nerves that sense pain have become damaged, and often painful. SFN pain is common, and it can affect sleep, memory, health and overall quality of life. Pregabalin is a drug commonly used to treat painful conditions, like nerve pain. It has been available to doctors for many years, and many studies have been performed to evaluate its effectiveness. In these studies, pregabalin has been shown to be very effective in the treatment of nerve pain, with fewer side effects than many other medications currently available. The purpose of the study is to determine if pregabalin relieves pain more effectively than a pill containing no medication (called a placebo). The study will also investigate any side effects as well as the effectiveness and safety of the medication.

Diabetic peripheral neuropathy is the most common complication to diabetes mellitus affecting as much as 50% of the population with diabetes. Symmetrical sensory neuropathy is by far the most common pattern, which often progress slowly over many years, although some individuals experience faster and more severe courses. Despite the frequent occurrence, the causes of diabetic peripheral neuropathy are largely unknown, which is reflected in the fact that no disease-modifying treatments are available for preventing, treating or even halting the progression of the disease. The consequences can be dire, as neuropathy frequently leads to foot ulcers, amputations or intolerable neuropathic pain in the lower extremities. Sensory loss may go completely undetected in diabetes, as there often are literally no symptoms. For many individuals, the development of diabetic peripheral neuropathy can therefore proceed completely unnoticed, making regular screening the most important tool for diagnosing the condition. Unfortunately, unlike nephropathy or retinopathy, diabetic peripheral neuropathy is not easily screened for, as the condition lacks reliable markers for early- or progressing disease. Therefore, screening for diabetic peripheral neuropathy currently revolves around diagnosing loss of protective sensation, judged by the inability to feel vibration or light touch. However, in their most recent guidelines, the American Diabetes Association has included screening for small fibre neuropathy using either the cold- and heat perception thresholds or pinprick as a clinical standard. Although this acknowledgement of the importance of assessing not only large- but also small nerve fibres is a huge step towards early detection of diabetic peripheral neuropathy, the overriding issue of insensitive, unreproducible, and inaccurate bedside tests for small nerve fibres remains. While cold- and heat perception and pinprick sensation are indeed mediated by small nerve fibres, the sensitivity of these methods, outside of extreme standardization only achievable in dedicated neuropathy research-centres, remain poor and not usable on an individual level. This lack of sensitivity has also become apparent in several large clinical trials, where the methods have continuously failed as robust clinical endpoints. Due to this, the hunt for a sensitive and reproducible method for adequate assessment of the small nerve fibres have begun. Amongst several interesting methods, two have gained particular interest (corneal confocal microscopy and skin biopsies with quantification of intra-epidermal nerve fiber density), due to their diverse strengths, although clinical application is currently limited to a few specialized sites. Furthermore, both methods suffer several inherent issues including that fact that they only provide information about the structure of the nerves and not the function. One method to assess the function of small cutaneous C-fibers is the assessment of the axon reflex flare response using laser doppler imaging (LDI) or Full-field laser perfusion imaging (FLPI), which has classically been studied using local heating. Unfortunately, this method is limited in clinical usage due to time-consumption. The investigators recently published an alternative method using a simple skin-prick application of histamine to evoke the response, which reduced the examination-time markedly. Before claiming the method to be a better alternative, the investigators do however need to prove that the method is as good as the original. In addition to the direct comparison of the histamine-induced and the heating-induced axon-reflex flare response the study will also assess spatial acuity in the same cohort as a secondary aim. Spatial acuity is considered as a measure of the sensory systems ability to code spatial information regarding an external stimulus. To investigate the spatial acuity, the 2-point discrimination task (2PDT) is often used. Spatial acuity has been shown to be impaired in several chronic pain condition. Additionally, it has been shown that the 2PDT may be a useful tool to understand the sensory changes in diabetes[8].

The purpose of this study is to assess safety and efficacy of treatment with pregabalin in patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched enrollment randomized withdrawal study that comprises 4 phases: a screening and selection phase, a washout period from previous pain medication for enriched enrollment, an 8 week single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.

The objective of this study is to develop a rationale for the selective treatment of small fiber neuropathy with immune globulin (IVIG) in the appropriate patients. The investigators hypothesize that individuals with auto-antibodies targeting neuronal antigens (TS-HDS and FGFR3) and confirmed evidence of small fiber neuropathy (by skin biopsy analysis of intra-epidermal nerve fiber density) will have an improvement in both nerve fiber density and pain after treatment with immune globulin. The co-primary endpoints will be a change in neuropathic pain (by VAS pain score) and a change in intra-epidermal nerve fiber density (by punch skin biopsy). The data gained from this pilot study will establish a rationale, with an appropriate screening test, for the use of immune globulin for the treatment of small fiber neuropathy.

The investigators will treat patients (targeting enrollment of n=20) who suffer from trigeminal or glossopharyngeal nerve pain in the context of painful small fiber neuropathy. The primary pain-related objective is reduction of pain and reduced use of rescue and other anti-pain medications. Another goal is to monitor and confirm the safety profile established in the migraine population, during previous Phase 3 trials.

This study is being done to evaluate cutaneous nerve biopsies from patients with refractory gastrointestinal motility disorders. The purpose of the study is to evaluate skin biopsies for signs of small fiber neuropathy in GI dysmotility patients, which may provide a better understanding of the underlying pathology of their condition. Specifically, identifying any small fiber neuropathy that may exist in the peripheral nervous system may help us to better understand the mechanism of presumed enteric neuropathy that may be involved in causing GI dysmotility.