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Clinical Trials
Seizure Disorders Marinus has completed a proof of concept Phase 2 clinical trial in refractory adult partial onset seizures using 1500 mg/day of the oral suspension formulation. This trial demonstrated a statistically significant reduction in seizure frequency as compared to placebo patients. Ganaxolone has been shown to be safe and well tolerated with chronic use in both refractory adult and pediatric patients. A Phase 2b study of a ganaxolone capsule formulation is planned to initiate in 2013. Posttraumatic Stress Disorder A clinical trial to investigate the safety and efficacy in PTSD patients is ongoing at seven US clinical sites. This study is being conducted by the INTRuST consortium, funded by a grant from the US Department of Defense. The study is currently enrolling subjects. For more information please visit www.clinicaltrials.gov NCT # 01339689. Fragile-X Syndrome The MIND institute at the University of California Davis (UCD) has recently been awarded a Department of Defense Medical Research Grant to study ganaxolone for treatment of behaviors in fragile-X syndrome (FXS). The grant was awarded to three UCD Principal Investigators: Randi Hagerman, MD, Michael Rogawski, MD, PhD, and David Hessl, PhD. The FXS clinical trial began enrollment in November 2012. Additional information about the trial is available on www.clinicaltrials.gov, NCT #01725152. To learn more about these clinical trial and for future studies of ganaxolone, please visit www.clinicaltrials.gov and search with keyword: MARINUS, or, contact us at clinicaltrials@marinuspharma.com.
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