ganaxolone

"It is encouraging to see these positive results for a novel compound such as ganaxolone," states Joyce Cramer, president of the Epilepsy Therapy Project.

Medlogs - Recent stories 2009

"It is encouraging to see these positive results for a novel compound such as ganaxolone," states Joyce Cramer, president of the Epilepsy Therapy Project.

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The Phase 2 trial was a randomized, double-blind, placebo-controlled trial evaluating ganaxolone as add-on therapy for adults with partial onset seizures, who continued to have seizures even while taking up to three antiepileptic drugs (AED).

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Marinus has successfully developed several proprietary and novel patented formulations of ganaxolone.

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Early epilepsy studies involved more than 100 patients and generated data supportive of the efficacy and safety of ganaxolone in the treatment of both children and adults suffering from refractory epilepsy (patients who continue to have seizures despite taking multiple anticonvulsant drugs).

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In this trial, ganaxolone demonstrated a statistically significant reduction in seizures versus placebo.

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Marinus Pharmaceuticals, Inc. today announced that it met its primary endpoint for its Phase 2 clinical trial investigating the safety and efficacy of ganaxolone as adjunctive therapy in adults with partial onset seizures, a type of epilepsy.

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Patients randomized to the ganaxolone treatment arm were titrated over one to two weeks to a maintenance dose of 1,500 mg / day where they were maintained for an additional 8 weeks.

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The discontinuation rates due to adverse events between placebo and ganaxolone arms were 6 percent and 7 percent, respectively.

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Patients were observed for baseline seizure activity for 8 weeks and were then randomized to receive either ganaxolone or placebo in addition to their existing stable AED regimen.

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