Small-Fiber Neuropathy Clinical Trial
Official title:
Evaluation of Pregabalin in Idiopathic Small Fiber Neuropathy
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.
Painful small fiber sensory neuropathy (SFN) is relatively common and a disabling medical
condition. It is the most common type of painful sensory neuropathy in patients older than 50
years of age. It is defined as a neuropathy that exclusively or predominantly affects the A-δ
(small myelinated) and nociceptive C (unmyelinated) nerve fibers and their functions. The
neuropathic pain associated with SFN is described by the patients as burning ("feet are on
fire"), sharp ("knife-like, jabbing or pins and needles"), shooting, and aching pain in the
toes and feet. The feet are described as tingling, numb, or feeling tight, wooden or dead.
The pain is disabling and often exacerbated at night interfering and disrupting the sleep
pattern. Allodynia and cramps may also occur. Some patients also describe pressure induced
pain in their feet with standing and walking. The autonomic nerves may be involved leading to
increased or decreased sweating, facial flushing, skin discoloration and erectile dysfunction
in up to 40% of males. On examination there is a dramatic mismatch between the symptoms and
observable deficits in SFN. Only abnormal findings are the loss of pinprick and temperature
sensations in feet that may extend up to the knees. Touch sensation may be diminished but
other sensations are usually preserved. By definition, patients with SFN are allowed to have
minor involvement of large fibers distally with reduced vibration in toes but the ankle
reflexes are usually preserved.
This study will be of a crossover design thus minimizing the number of subjects needed. Each
patient will act as his/her own control. Previous studies of pregabalin have shown that the
desired effect is achieved by eight weeks of treatment. Therefore each patient will start on
either placebo or pregabalin. They will be assessed on this treatment arm for eight weeks.
There will be a two-week drug tapering and washout period before switching treatments,
followed by re-assessment for an additional eight weeks. This design minimizes the amount of
time that the patient will be treated with placebo.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01078857 -
Small-fiber Neuropathy in Chronic Kidney Disease
|
N/A |