Kissei announces the publication of the results of phase III trials of rovatirelin for the treatment of spinocerebellar degeneration in the Journal of Neurology, Neurosurgery, and Psychiatry;
Kissei Pharmaceutical Co., Ltd. announced that the results of two phase III clinical trials of rovatirelin discoverd by Shionogi & Co., Ltd.for the treatment of spinocerebellar degeneration have recently been published in a medical journal, the online version of the Journal of Neurology, Neurosurgery, and Psychiatry
Kissei conducted an initial phase III clinical trial of rovatirelin from 2013 to 2015. Based on the results of the initial phase III clinical trial, Kissei conducted an additional phase III clinical trial starting from 2016 to 2018. The primary endpoint of these trials was the mean change from baseline in total SARA score for the assessment of ataxia. However, a statistically significant difference from the placebo-controlled group was not determined.
In this paper, to review the results of both phase III clinical trials, a pooled (post hoc) analysis was performed with patients who met the inclusion criteria for the additional phase III trial, which comprised patients with a more severe condition. The change in total SARA score in the rovatirelin 2.4 mg group indicated a statistically significant improvement compared with the placebo group (a 1.64-point improvement in the rovatirelin 2.4 mg group and a 1.03-point improvement in the placebo group).
With regard to safety, it was reported that the most common adverse events (5% or more) in the rovatirelin group were nasopharyngitis, nausea, weight decreased, and contusion; most were mild in severity. Based on the results of these analyses, Kissei is still under discussion about the future process with the Japanese Pharmaceuticals and Medical Devices Agency. Rovatirelin has not yet been approved for the treatment of spinocerebellar degeneration.
See-"Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase III trials"- Masatoyo Nishizawa, Osamu Onodera, Akihiro Hirakawa, Yoshitaka Shimizu, Masayuki Yamada on behalf of the Rovatirelin Study Group.-http://dx.doi.org/10.1136/jnnp-2019-322168.
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