The main purpose of this study is to compare the change in pain intensity during treatment with a sodium-channel blocker (lacosamide) in patients with peripheral neuropathic pain with and without the irritable nociceptor phenotype.
The main purpose of this study is to compare the change in pain intensity during treatment with a sodium-channel blocker (lacosamide) in patients with peripheral neuropathic pain with and without the irritable nociceptor phenotype. As this is a mechanistic study, the main purpose is to compare the change in pain intensity in patients who receive an expected sufficiently effective dose of lacosamide. As supportive evidence for a drug-specific predictive biomarker, the purpose is also to compare the change in pain intensity during lacosamide vs. placebo for the two phenotypes. We hypothesize that the sodium-channel blocker lacosamide will be more effective in patients with the irritable nociceptor than those without the non-irritable nociceptor phenotype, and that lacosamide is more effective than placebo in patients with the irritable nociceptor phenotype.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
Lacosamide (50 mg) and identical placebo are given as capsules and taken orally twice a day, up to 200 mg b.i.d.
Identical placebo are given as capsules and taken orally twice a day.
Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark
Pain intensity
The difference in the mean value of the patient's daily ratings of average pain intensity in the baseline week and the last week during treatment as experienced during the past 24 hours rated on a 0-10 point numeric rating scale (NRS; 0 = no pain, 10 = worst possible pain). The primary objective is to compare the change in pain intensity from baseline to last week of lacosamide treatment in patients with and without the irritable nociceptor phenotype in the PP population. The supportive objective is to compare the effect of lacosamide vs. placebo in the two phenotype groups in the PP population. Although we do not expect a phenotype difference in the response to placebo, a comparison of the effect of lacosamide vs. placebo is needed to justify that the phenotype is a predictive biomarker for the effect of lacosamide.
Time frame: 12 weeks
Pain relief
(complete, good, moderate, mild, none, worse pain) . Measured at last visit/end of treatment period.
Time frame: 12 weeks
Use of escape medicine (paracetamol) during treatment period.
Number of paracetamol tablets during the 12 weeks treatment period.
Time frame: 12 weeks
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