Ignite Creation Date:
2024-05-06 @ 1:33 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01835665
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2013-03-27
Brief Title:
Dose Finding Study of Nimodipine for the Treatment of Progranulin Insufficiency From GRN Gene Mutations
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
An Open Label Dose Finding Study of Nimodipine for the Treatment of Progranulin Insufficiency From GRN Gene Mutations
Status:
COMPLETED
Status Verified Date:
2016-05
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 purpose of this study is to determine the maximum tolerated dose of nimodipine as well as the safety and tolerability of oral nimodipine in progranulin mutation carriers in preparation for longer term efficacy studies in patients with frontotemporal dementia due to progranulin gene mutations
Detailed Description:
8 people with a GRN gene mutation will be given escalating doses of oral nimodipine for four weeks followed by the maximally tolerated dose for four weeks To maximize enrollment the trial will enroll both symptomatic and asymptomatic GRN mutation carriers The trial will include a four week dose-escalation phase followed by 1-month maintenance phase and a 1-week taper Assessments at the study site will take place prior to starting nimodipine each week the dose is increased weeks 1-5 after 4 weeks of maintenance dose and 2 weeks after completion of the study These will include blood chemistry tests ECGs and blood pressure Both dose escalation and maintenance will focus on safety and tolerability of nimodipine treatment in this population as well as plasma progranulin levels as a biomarker outcome The trial will incorporate a variety of other fluid biomarker blood and CSF and imaging assessments to determine which will be most sensitive to nimodipine pharmacodynamic effects in this population
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