Neurotune announces regulatory approval for Phase II Clinical Trial to treat neuropathic pain in HIV patients
Neurotune AG has received MCC ’s (the South African National Regulatory Agency) approval for a Phase II clinical study of neurotune’s lead compound NT-11624 for neuropathic pain caused by treatment with anti-retroviral medication.
Neurotune’s Phase II trial (8-week, randomized, double-blind, placebo-controlled, parallel group study) will evaluate the safety and efficacy of NT-11624 (dimiracetam) in the treatment of neuropathic pain, a common side effect of antiretroviral medications. The primary objective of the Phase II study is to assess the drug’s safety in patients under polytherapy for HIV. A secondary objective is to estimate the beneficial effect of dimiracetam on the reduction of pain compared to placebo. The Visual Analogue Scale (VAS) and the Total Symptom Score (TSS) will be primarily used to assess the improvement in symptoms after treatment from baseline through to week eight. The study will enroll at least 100 patients with a planned completion of the study in the middle of 2010.
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