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news.Valeant Pharmaceuticals has enrolled the first patient in its randomized, double-blind, placebo-controlled Phase II clinical trial of retigabine for the treatment of pain associated with postherpetic neuralgia, a painful and common complication of shingles.
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This proof-of-concept study is designed to enroll a total of 180 patients with 120 patients randomized to treatment with retigabine and 60 randomized to placebo treatment for a treatment period of up to 10 weeks. The study will be conducted in up to 40 trial locations.
Study patients will be titrated to their individually determined maximum tolerated dose within the range of 300mg to 900mg per day. The primary outcome assessment will be the comparison of the average pain intensity over the last seven days of maintenance therapy with retigabine versus placebo. Pain intensity will be measured on a standard 0-10 numerical rating scale.
Timothy Tyson, president and CEO, said: “We are eager to investigate whether retigabine, our new novel potassium channel opener, will be effective in treating neuropathic pain. Retigabine shows promise as an effective analgesic in animal pain models. We are optimistic that retigabine might offer a much-needed, new option for physicians treating patients with debilitating and painful conditions such as postherpetic neuralgia.”