Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-01-04 @ 4:55 AM
Study NCT ID:
NCT04026750
Status:
TERMINATED
Last Update Posted:
2021-04-02
First Post:
2019-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Insulin Tolerance Test Study in Patients With Type 1 Diabetes
Sponsor:
High Point Clinical Trials Center
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Insulin Tolerance Test Study to Assess the Safety, Tolerability, and Pharmacodynamics OF Pitolisant in Patients With Type 1 Diabetes
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on scientific data collected during the trial and high screen fail rate.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes
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?: