Journal of the peripheral nervous system : JPNS
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J. Peripher. Nerv. Syst. · Dec 2015
Randomized Controlled TrialSafety and efficacy of ranirestat in patients with mild-to-moderate diabetic sensorimotor polyneuropathy.
We examined the efficacy and safety of ranirestat in patients with diabetic sensorimotor polyneuropathy (DSPN). Patients (18-75 years) with stable type 1/2 diabetes mellitus and DSPN were eligible for this global, double-blind, phase II/III study (ClinicalTrials.gov NCT00927914). Patients (n = 800) were randomized 1 : 1 : 1 to placebo, ranirestat 40 mg/day or 80 mg/day (265 : 264 : 271). ⋯ There was no effect of ranirestat on safety assessments, secondary or exploratory endpoints vs. placebo. Ranirestat was well tolerated and improved PMNCV, but did not achieve any efficacy endpoints. The absence of PMNCV worsening in the placebo group underscores the challenges of DSPN studies in patients with well-controlled diabetes.
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J. Peripher. Nerv. Syst. · Oct 2014
Randomized Controlled TrialA mechanistic approach to the use of topical therapy to treat neuropathic pain.
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J. Peripher. Nerv. Syst. · Dec 2013
Randomized Controlled Trial Multicenter Study Clinical TrialA controlled trial of intravenous immunoglobulin in multifocal motor neuropathy.
Intravenous immunoglobulin (IVIG) has become the standard treatment for multifocal motor neuropathy (MMN) based on limited data. To critically assess the efficacy, safety, and tolerability of 10% liquid IVIG (IVIG), 44 adults with MMN were randomized 1 : 1 to either double-blind treatment of IVIG followed by placebo for 12 weeks each or the reverse. Open-label IVIG was administered for 12 weeks at the beginning and end of the study for clinical stabilization, and between double-blinded periods to prevent a carry-over effect. ⋯ Sixty-nine percent (69.0%) switched prematurely from placebo to open-label IVIG and 2.4% switched from blinded to open-label IVIG (p < 0.001). One serious adverse reaction (pulmonary embolism) and 100 non-serious reactions (69 mild, 20 moderate, and 11 severe) to IVIG occurred. IVIG was effective in improving disability and muscle strength, and was safe and well tolerated in adults with MMN.
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J. Peripher. Nerv. Syst. · Dec 2001
Randomized Controlled Trial Clinical TrialRelative sensitivity to alfentanil and reliability of current perception threshold vs von Frey tactile stimulation and thermal sensory testing.
Recent technological advances claim to allow quantitative measurement of the functional integrity of both large and small diameter sensory nerve fibers using the current perception threshold (CPT) sensory testing device. This device has yet to be validated against the corresponding gold standard references for sensory testing (thermal sensory testing [TST]) and von Frey tactile hair stimulation [VF]) to correlate its evaluation of similar sensory nerve perceptions. A baseline neurosensory examination using the CPT, TST and VF methods was performed on 19 healthy volunteers. ⋯ In addition, there was no effect of alfentanil on the VF or the CPT 2000 Hz thresholds. However, we did not see the predicted relation between the 250 Hz CPT stimulus and cool sensation. From these studies, there is some evidence that similar fiber tracts may be measured between the CPT, TST, and VF methods, especially with the CPT 5 Hz measures and C-fiber tract activity.