A Phase 2 interventional study of ganaxolone in Epilepsy, Complex Partial, sponsored by Marinus Pharmaceuticals. Completed at 7 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by Marinus Pharmaceuticals · Phase 2, Interventional, and Treatment
This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.
Marinus Pharmaceuticals is the lead sponsor of 22 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
all subjects participating in 0602 are receiving ganaxolone for seizure control
Drug: ganaxolone
liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year
Also known as: CCD 1042, CAS 383-98323-2, 3 alpha-hydroxy, 3 beta-methyl, 5 alpha-pregnan-20-one
Investigators Global Assessment
Investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. The investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. Responses categories were Improved Markedly, Improved Moderately, Improved Slightly and No change from baseline.
Time frame: Screening through 52 weeks
The study population was to have completed all scheduled clinical study visits in the previous protocol 1042-0601 and have been deemed eligible by the Investigator including no major adverse events \[AEs\] thought to be drug related and deriving benefit from ganaxolone treatment.
| Milestone | Ganaxolone |
|---|---|
| Started | 11 |
| Completed | 7 |
| Not completed | 4 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lack of efficacy | 1 |
Investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. The investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. Responses categories were Improved Markedly, Improved Moderately, Improved Slightly and No change from baseline.
| Participants | Ganaxolone |
|---|---|
| Improved Markedly - Visit 1 - Screening | 6 |
| Improved Moderately - Visit 1 - Screening | 4 |
| Improved Slightly - Visit 1 - Screening | 0 |
| No change from baseline - Visit 1 - Screening | 1 |
| Improved Markedly - Visit 2 - Week 26 | 3 |
| Improved Moderately - Visit 2 - Week 26 | 4 |
| Improved Slightly - Visit 2 - Week 26 | 0 |
| No change from baseline - Visit 2 - Week 26 | 0 |
| Improved Markedly - Visit 3 - Week 52 or Taper Visit | 2 |
| Improved Moderately - Visit 3 - Week 52 or Taper Visit | 4 |
| Improved Slightly - Visit 3 - Week 52 or Taper Visit | 1 |
| No change from baseline - Visit 3 - Week 52 or Taper Visit | 1 |
Collected over Screening (0601 visit 12/last visit) through Visit 4 (week 56 - last visit). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ganaxolone | 0/11 (0%) | 1/11 (9.1%) | 8/11 (72.7%) |
| Event | Ganaxolone |
|---|---|
| Tension headacheNervous system disorders | 1/11 |
| Transient ischemic attackNervous system disorders | 1/11 |
| Aortic aneurysmVascular disorders | 1/11 |
| Event | Ganaxolone |
|---|---|
| IrritabilityGeneral disorders | 2/11 |
| HeadacheNervous system disorders | 2/11 |
| DiarrheaGastrointestinal disorders | 1/11 |
| VomitingGastrointestinal disorders | 1/11 |
| FatigueGeneral disorders | 1/11 |
| Oedema PeripheralGeneral disorders | 1/11 |
| Nail TineaInfections and infestations | 1/11 |
| Tinea PedisInfections and infestations | 1/11 |
| Urinary Tract InfectionInfections and infestations | 1/11 |
| ContusionInjury, poisoning and procedural complications | 1/11 |
ITT Population
| Age, Categorical(Participants) | Ganaxolone |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 0 |
| Age, Continuous(years) | Ganaxolone |
|---|---|
| Mean | 44.5 ± 10.35 |
| Sex: Female, Male(Participants) | Ganaxolone |
|---|---|
| Female | 8 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Ganaxolone |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Ganaxolone |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Epilepsy, Complex Partial
Marinus Pharmaceuticals