EpiCept pain drug to enter late-stage trials

The study will be conducted within a network of approximately 25 sites under the direction of the National Cancer Institute funded Community Clinical Oncology Program, according to the company. EpiCept expects to initiate the trial before the end of the third quarter of 2007.

The double-blind, randomized placebo-controlled study will enroll approximately 400 patients suffering from painful chemotherapy induced peripheral neuropathy (CPN) for at least 28 days following the conclusion of chemotherapy.

The trial will be 12 weeks in duration, with the primary endpoint being the change in average daily pain intensity scores from baseline to the end point. The secondary endpoints include the percentage of patients whose pain intensity decreases greater or equal to 30% from baseline and various other measures.

Peripheral neuropathy, a painful condition caused by damage to the nerves in the peripheral nervous system, affects over 15 million people in the US. CPN is the result of the toxicity of a number chemotherapeutic agents. The risk of neuropathy increases with cumulative exposure. The first symptoms are paresthesias, with dysesthesias occurring after a few courses of chemotherapy, and often followed by severe neuropathic pain.