Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441896
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2007-02-27
Brief Title:
A Randomized Controlled Trial of Ganaxolone in Patients With Infantile Spasms
Sponsor:
Marinus Pharmaceuticals
Organization:
Marinus Pharmaceuticals
Study Overview
Official Title:
A Double-blind Placebo-controlled Dose-ranging Clinical Study to Evaluate the Safety Tolerability and Antiepileptic Activity of Ganaxolone in Treatment of Patients With Infantile Spasms
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study consists of cohorts where participants are randomized in a 21 ratio to 1 of 2 sequences A and B In each cohort Sequence A comprised of participants who will receive ascending doses of ganaxolone and ascending doses of placebo Sequence B comprised of participants who will receive ascending doses of placebo and ascending doses of ganaxolone The dosing level in each subsequent cohort will be based upon experience gained from previous cohorts
Detailed Description:
Male or female 4 to 24 months of age inclusive with a diagnosis of IS with a 24 hour video EEG vEEG recording confirming the diagnosis and previously treated with 3 or fewer antiepileptic drugs AEDs are eligible for the study The subject is able to continue treatment with concomitant AEDs no more than 2 adrenocorticotropic hormone ACTH corticosteroids felbamate and vigabatrin are not allowed concomitantly A ketogenic diet is permitted if it can be maintained for the duration of the study
There will be a total of three weekly 24-hr video EEGs baseline end of weeks 1 and 2 of treatment Dosing titration begins the day after each video EEG during the inpatient stay All subjects will be receiving ganaxolone the day after the second video EEG
A Data Monitoring Board DMB will determine whether successive cohorts of subjects can be dosed at an increased dose level up to a maximum of 6 cohorts
There will be a total of three weekly 24-hr video EEGs baseline end of weeks 1 and 2 of treatment Dosing titration begins the day after each video EEG during the inpatient stay All subjects will be receiving ganaxolone the day after the second video EEG
A Data Monitoring Board DMB will determine whether successive cohorts of subjects can be dosed at an increased dose level up to a maximum of 6 cohorts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None