Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04153175
Status:
TERMINATED
Last Update Posted:
2024-03-13
First Post:
2019-11-03
Brief Title:
Study to Assess Intracerebroventricular ICV Delivery of CT-010 in Subjects With Focal Seizures With Temporal Lobe Onset With or Without Secondary Generalization
Sponsor:
Cerebral Therapeutics LLC
Organization:
Cerebral Therapeutics LLC
Study Overview
Official Title:
A Phase 2 Double-Blind Randomized Placebo-Controlled Study to Assess Intracerebroventricular ICV Delivery of CT-010 Via an Implantable Pump and a Cranial Port and Double Lumen Catheter ICVRX in Subjects With Focal Seizures With Temporal Lobe Onset With or Without Secondary Generalization
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 double-blind randomized placebo-controlled study to assess the safety and efficacy of ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter CIC in subjects with focal seizures with temporal lobe onset with or without secondary generalization Up to 70 subjects will be enrolled Eligible subjects will be randomized in a 11 ratio to either CT-010 or placebo treatment Up to 20 clinical centers will be enrolled
Detailed Description:
Epilepsy patients that are refractory to oral anti-epileptic drug AED treatment have significantly higher mortality higher morbidity higher economic costs and diminished quality of life compared to those who suffer from epilepsy that can be adequately controlled with medical management Current options for refractory patients include neurosurgical brain resection responsive neurostimulation and vagal nerve stimulation None of these options is satisfactory due to the low applicability of surgery for patients with poorly localized or multifocal seizures and the limited success of currently available alternative treatment options
In this study patients with medically refractory focal epilepsy will be treated with intracerebroventricular ICV administration of CT-010 a reformulation of valproate using an implantable drug pump system This is a randomized double-blind Phase 2 study evaluating the efficacy and safety of this therapy Clinical assessments adverse events AEs seizure diaries concomitant medications blood samples and cerebrospinal fluid CSF will be collected and reviewed at designated time points Magnetic resonance imaging MRI and electroencephalography EEG will also be performed Subjects will have their surgery dose changes and pharmacokinetics performed in an inpatient setting
Subjects will be enrolled based on InclusionExclusion Criteria and undergo a 6-week baseline period confirming and establishing monthly seizure rate Following the baseline period subjects will undergo system implant and a 1-month implant recovery period Following successful implant and recovery subjects will be randomized to either active therapy or placebo for a 3-month blinded evaluation period At the conclusion of the blinded evaluation period subjects will roll into an Open Label Extension Period CLN100P02 Subjects that were randomized to placebo will receive active therapy during CLN100P02
In this study patients with medically refractory focal epilepsy will be treated with intracerebroventricular ICV administration of CT-010 a reformulation of valproate using an implantable drug pump system This is a randomized double-blind Phase 2 study evaluating the efficacy and safety of this therapy Clinical assessments adverse events AEs seizure diaries concomitant medications blood samples and cerebrospinal fluid CSF will be collected and reviewed at designated time points Magnetic resonance imaging MRI and electroencephalography EEG will also be performed Subjects will have their surgery dose changes and pharmacokinetics performed in an inpatient setting
Subjects will be enrolled based on InclusionExclusion Criteria and undergo a 6-week baseline period confirming and establishing monthly seizure rate Following the baseline period subjects will undergo system implant and a 1-month implant recovery period Following successful implant and recovery subjects will be randomized to either active therapy or placebo for a 3-month blinded evaluation period At the conclusion of the blinded evaluation period subjects will roll into an Open Label Extension Period CLN100P02 Subjects that were randomized to placebo will receive active therapy during CLN100P02
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None