Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563817
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
The Safety and Efficacy of Rapamycin on Communicating Hydrocephalus Secondary to Intraventricular Hemorrhage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multi-center Open-label Study to Observe the Efficacy and Safety of Rapamycin in the Treatment of Communicating Hydrocephalus Secondary to Intraventricular Hemorrhage
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Saturn
Brief Summary:
This prospective multicenter open-label clinical trial is designed to evaluate the safety and efficacy of rapamycin in the treatment of communicating hydrocephalus secondary to intraventricular hemorrhage Additionally the underlying pathogenic mechanisms associated with this particular type of hydrocephalus will be investigated in greater depth and populations that may benefit from rapamycin therapy will be identified
Detailed Description:
Communicating hydrocephalus secondary to intraventricular hemorrhage is a serious neurological disorder with the main clinical manifestations of ventricular dilatation gait disturbance cognitive dysfunction and urinary incontinence At present the sole treatment option for these patients is cerebrospinal fluid shunting However complications resulting from this therapy have necessitated multiple surgeries for some patients which has a significant impact on their quality of life and financial resources However recent studies have identified the PI3K-AKT-mTOR pathway as a key contributor to the sequelae of hemorrhagic hydrocephalus Furthermore these studies demonstrated that rapamycin an inhibitor of the PI3K-AKT-mTOR pathway inhibited cerebrospinal fluid secretion and ventricular dilation in an animal model of hemorrhagic hydrocephalus sequelae In light of these findings we propose a prospective multicenter open-label clinical trial to evaluate the efficacy and safety of rapamycin in the treatment of communicating hydrocephalus secondary to intraventricular hemorrhage
The study design was that of a prospective multicenter open-label clinical trial All patients were administered sirolimus rapamycin in a dosage of 05 mg per capsule The capsules were provided by the North China Pharmaceutical Company and were stored at room temperature The treatment course was four weeks with a dosage of 15 mg orally per day Efficacy and adverse effects were assessed at two weeks four weeks the end of treatment and 12 weeks after the end of treatment respectively
The study design was that of a prospective multicenter open-label clinical trial All patients were administered sirolimus rapamycin in a dosage of 05 mg per capsule The capsules were provided by the North China Pharmaceutical Company and were stored at room temperature The treatment course was four weeks with a dosage of 15 mg orally per day Efficacy and adverse effects were assessed at two weeks four weeks the end of treatment and 12 weeks after the end of treatment respectively
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