Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04658823
Status:
UNKNOWN
Last Update Posted:
2022-03-24
First Post:
2020-11-29
Brief Title:
Efficacy and Safety of Tocotrienols in CADASIL
Sponsor:
Hovid Berhad
Organization:
Hovid Berhad
Study Overview
Official Title:
A Randomized Placebo-controlled Double-blind Pilot Phase II Study to Assess the Efficacy and Safety of HOV-12020 in Patients With Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy CADASIL
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
CADASIL is a paradigmatic cerebral small vessel disease responsible for white-matter lesions accumulation of lacunes microbleeds and cerebral atrophy The disease is responsible for stroke and cognitive decline associated with motor disability The number of incident lacunes and amount of cerebral atrophy were recently found to have a strong relationship to cognitive decline and disability progression over 3 years in a large sample of patients Palm tocotrienols has previously shown evidence of therapeutic effect in attenuating the progression of WMH related to sporadic cerebral small vessel disease in a randomized controlled clinical trial We hypothesize that palm tocotrienols complex HOV-12020 can reduce the clinical progression in CADASIL
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None