Drug updated on 11/5/2024
| Dosage Form | Suspension (oral; 50 mg/mL) |
| Drug Class | Neuroactive steroid gamma-aminobutyric acid modulators |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
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Summary
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Ganaxolone demonstrated a significant improvement in achieving a ≥50% reduction in mean seizure frequency compared to placebo, with a Risk Ratio (RR) of 1.60, 95% Confidence Interval (CI): 1.02-2.49, p = 0.04, I² = 30%.
- No statistically significant difference was observed between ganaxolone and placebo in the percentage of seizure-free days (p = 0.36).
- The abstract does not mention any specific population types or subgroups regarding effectiveness outcomes.
- There was no significant difference in the occurrence of adverse events, serious adverse events, or adverse events leading to study drug discontinuation between ganaxolone and placebo (p > 0.05).
- No specific safety concerns or adverse effects were highlighted in particular population types or subgroups.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ztalmy (ganaxolone) Prescribing Information. | 2024 | Marinus Pharmaceuticals, Inc., Radnor, PA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| The efficacy and safety of ganaxolone for the treatment of refractory epilepsy: A meta-analysis from randomized controlled trials. | 2023 | Epilepsia Open |