CLINICAL TRIALS PROFILE FOR GANAXOLONE
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All Clinical Trials for ganaxolone
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00441896 ↗ | A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms | Completed | Marinus Pharmaceuticals | Phase 2 | 2007-01-01 | The study is a two period (8-10 days/period), incomplete cross-over in which successive cohorts of 9 subjects are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of 6 subjects, receives ascending doses of ganaxolone during period 1 and ganaxolone (at the maximal dose attained in period 1) and ascending doses of placebo during period 2. Sequence B, comprised of 3 subjects, receives ascending doses of placebo during period 1 and receives the maximum dose of placebo and ascending doses of ganaxolone during period 2. The dosing level in each subsequent cohort will be based upon experience gained from previous cohorts. |
| NCT00442104 ↗ | Open-label Extension to Protocol 1042-0500 | Terminated | Marinus Pharmaceuticals | Phase 2 | 2007-01-01 | To allow open-label extension to patients who have completed Protocol 1042-0500 |
| NCT00465517 ↗ | A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures | Completed | Marinus Pharmaceuticals | Phase 2 | 2007-02-01 | The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy. Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle. |
| NCT00512317 ↗ | Open-label Extension to Protocol 1042-0600 | Completed | Marinus Pharmaceuticals | Phase 2 | 2007-06-01 | To allow open-label extension to patients who have completed Protocol 1042-0600. |
| NCT01002820 ↗ | A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601 | Completed | Marinus Pharmaceuticals | Phase 2 | 2009-10-01 | This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601. |
| NCT01339689 ↗ | Ganaxolone in Posttraumatic Stress Disorder (PTSD) | Completed | INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium | Phase 2 | 2011-04-01 | This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, 15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress Disorder (PTSD). Up to 120 subjects will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. After 6 wks of randomized treatment all subjects will continue for 6 wks on ganaxolone. The aim of the study is to assess the efficacy of ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to evaluate the safety and tolerability of ganaxolone in the PTSD population. |
| NCT01339689 ↗ | Ganaxolone in Posttraumatic Stress Disorder (PTSD) | Completed | U.S. Army Medical Research and Development Command | Phase 2 | 2011-04-01 | This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, 15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress Disorder (PTSD). Up to 120 subjects will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. After 6 wks of randomized treatment all subjects will continue for 6 wks on ganaxolone. The aim of the study is to assess the efficacy of ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to evaluate the safety and tolerability of ganaxolone in the PTSD population. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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