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.
Patients who show any increase in their pain intensity score during the washout phase will be eligible for the single blind pregabalin treatment phase. Patients who respond to pregabalin, with at least 1 point improvement in neuropathic pain from baseline at the end of the single blind pregabalin treatment phase and meeting all other study requirements are considered eligible for participation in the withdrawal phase. These eligible patients are randomly assigned (1:1) to continue pregabalin or to be switched to placebo for a comparison of pregabalin efficacy and safety. Patients who have a worsening of average pain relative to the last week of the single blind pregabalin treatment period by more than one point and average pain level \> =4 will be considered to have a loss of therapeutic response (LTR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
11
Pregabalin will be given to the patients, starting at 75 mg BID and increased weekly to reach 225 mg BID for 8 weeks. During withdrawal phase, dose of pregabalin will be kept the same for patients who are randomized to the pregabalin withdrawal group.
Placebo will be given to the patients that are randomized to placebo during withdrawal phase.
Johns Hopkins Hospital
Baltimore, Maryland, United States
Visual Analogue Score for Pain Intensity.
The primary outcome is change in visual analogue score for pain, with 0 being no pain at all and 10 being the most severe pain and a higher score meaning more pain, after 8 weeks of treatment phase and 4 weeks of randomized withdrawal phase.
Time frame: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
Brief Pain Inventory (BPI sf);
Brief pain inventory is a scoring system for average pain intensity on scale of 0-10 with higher number meaning more pain.
Time frame: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS);
a scoring system describing sleep quality between 0-10 with 0 having no problem with sleep and 10 not being to sleep at all.
Time frame: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
Patient Global Impression of Change (PGIC);
patient assign a number between 1-7 to the level of improvement, 1 showing substantial improvement and 7 showing no improvement at all.
Time frame: At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
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