The reduction of muscle spasm, a secondary endpoint, also failed to achieve statistical significance. There were no safety issues. The trial was adequately powered, and all statistical parameters were in line with expectations.
This double-blind, randomized clinical trial was conducted in 27 multiple sclerosis (MS) centers in Germany and other European countries to evaluate safety, tolerability, pharmacokinetics and efficacy in up to 150 MS patients suffering from spasticity. This trial was being conducted to good clinical practice standards by an international clinical research organization. Following a five-week double blind assessment, patients were offered the opportunity to continue for up to 12 months in an open-label safety Phase.
The primary efficacy endpoint was the Ashworth scale, a standard tool used in the clinic to measure increased resistance to passive limb movement. Secondary endpoints included brief pain index, painful spasm diaries, and clinical impression of change.
Kenneth Chahine, president and CEO of Avigen, said: “We are disappointed with the result of this trial. We had hoped AV650 would become an important new treatment option for people in the US who currently suffer from spasticity. While we will continue to review the additional data from the trial and consider further options, we are confident in the trial design and the quality of the top-line results.”