TI presents first double-blind data supporting phenytoin 10% cream in painful polyneuropathies at FIGON Dutch Medicines Days
Every year FIGON (Federatie Innovatie Geneesmiddel Onderzoek Nederland: Dutch Federation Innovative Medicine Research) is organizing a 2-day conference. On the 23rd of September 2019 at the FIGON Dutch Medicines Days David Kopsky on behalf of TI has presented the first double-blind data gathered with phenytoin 10% cream in a mixed population suffering from painful polyneuropathies (poster).
Title of the poster: Double-blind placebo-controlled response test with phenytoin 10% and placebo creams in patients with painful polyneuropathies, abstract number: ABS-67542729.
He presented the results of the first series of 14 patients where we tested the DOBRET. The series can be regarded as a collection of N-of-1 or single subject clinical trials, presenting level 1 evidence according to the Oxford Centre for Evidence-Based Medicine. Pre-treatment pain intensity scores on the 11-point numerical rating scale (NRS) in both groups were comparable, around 6. Six patients (42.9%) were labeled as responders, and in this group the mean pain was reduction in the phenytoin 10% cream applied area was 3.1 (SD: 0.3) compared to 1.8 (SD: 0.4) in the placebo cream applied area. No side effects were detected. These data were in line with the outcome of our first single blind case collection of 21 patients, our case collection of 70 patients, and our first case reports supporting further development of topical phenytoin cream in peripheral neuropathic pain.