Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome

Summary

The objective of this study is to evaluate the long-term safety and effectiveness of open-label clobazam in the treatment of drop seizures in subjects with LGS.

Timeline

Start

2005-12

Primary completion

2012-02

Completion

2012-02

Publications

• Results Ng YT, Conry J, Paolicchi J, Kernitsky L, Mitchell W, Drummond R, Isojarvi J, Lee D, Owen R; OV-1004 study investigators. Long-term safety and efficacy of clobazam for Lennox-Gastaut syndrome: interim results of an open-label extension study. Epilepsy Behav. 2012 Dec;25(4):687-94. doi: 10.1016/j.yebeh.2012.09.039. Epub 2012 Nov 7.
• Results Ng YT, Conry J, Kernitsky L, Mitchell W, Veidemanis R, Drummond R, Muniz R, Isojarvi J, Lee D, Paolicchi J. Long-Term Safety and Efficacy of Clobazam for Lennox-Gastaut Syndrome: Final Results of an Open-Label Extension Study. Late-Breaking Abstract #1.363 presented at the 66th annual meeting of the American Epilepsy Society, Nov. 30-Dec. 4, 2012, San Diego, California.
• Gidal BE, Wechsler RT, Sankar R, Montouris GD, White HS, Cloyd JC, Kane MC, Peng G, Tworek DM, Shen V, Isojarvi J. Deconstructing tolerance with clobazam: Post hoc analyses from an open-label extension study. Neurology. 2016 Oct 25;87(17):1806-1812. doi: 10.1212/WNL.0000000000003253. Epub 2016 Sep 28.

Drugs

Indications