Status:
NO_LONGER_AVAILABLE
Ganaxolone Expanded Access Program Compassionate Use
Lead Sponsor:
Marinus Pharmaceuticals
Conditions:
CDKL5 Disorder
Eligibility:
All Genders
2+ years
Brief Summary
The primary objective is to provide GNX to patients ≥ 2 years with CDD-related seizures who are refractory to, or intolerant of, standard therapy.
Detailed Description
This is a multi-center, long-term, open-label, expanded access protocol of adjunctive GNX treatment in children, adolescents, and adults with CDD. Patients with inadequate seizure control on their cur...
Eligibility Criteria
Inclusion
- Molecular confirmation of a pathogenic CDKL5 variant, early onset, difficult to control seizures, and neurodevelopmental impairment are required. Male or female patients aged ≥ 2 years. In the opinion of the investigator, the patient has inadequate seizure control on current anti-seizure medications at therapeutic doses.
Exclusion
- \-
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04678479
Last Update
January 22 2024
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