clinical trial · NCT00442104
Open-label Extension to Protocol 1042-0500
Infantile SpasmsGanaxolone
brief summary
To allow open-label extension to patients who have completed Protocol 1042-0500
started
Jan 1, 2007
primary completion
Mar 1, 2009
completion
Mar 1, 2009
last updated
May 28, 2024
detailed description
Patient should have completed all scheduled clinical study visits in the double blind, controlled trial (Protocol 1042-0500) and have been deemed eligible (had a response to treatment) by the Investigator. Male or female, with a diagnosis of IS with a video EEG (vEEG) recording confirming the diagnosis.
There will be a total of 14 visits over 99(+or-1)week. A 24-hr vEEG is only required if the subject has been spasm-free for more than 24-hrs.
official title
An Open-label Clinical Study to Evaluate the Safety and Antiepileptic Activity of Ganaxolone in Treatment of Patients Diagnosed With Infantile Spasms.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol