Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643481
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis ALS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo-controlled Parallel Group Study of VHB937 in Amyotrophic Lateral Sclerosis ALS Over 40 Weeks Followed by an Open Label Extension ASTRALS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
ASTRALS
Brief Summary:
This is a multicenter randomized double-blind placebo-controlled parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early-stage ALS within 2 years of ALS symptoms onset The study comprises a core double-blind DB 40-week treatment period followed by an open label extension OLE
Detailed Description:
The main questions this trial aims to answer in comparing VHB937 to placebo are
How long will participants live without needing permanent help from a machine to breathe after starting the trial treatment
What is the change in the participants ability to perform daily activities This will be measured using a questionnaire called the amyotrophic lateral sclerosis functional rating scale-revised ALSFRS-R
What adverse events are reported during this trial An adverse event is any sign or symptom that participants have during a trial Adverse events may or may not be caused by treatments in the trial The trial doctors will check participants ALS and general health throughout the trial
How long will participants live without needing permanent help from a machine to breathe after starting the trial treatment
What is the change in the participants ability to perform daily activities This will be measured using a questionnaire called the amyotrophic lateral sclerosis functional rating scale-revised ALSFRS-R
What adverse events are reported during this trial An adverse event is any sign or symptom that participants have during a trial Adverse events may or may not be caused by treatments in the trial The trial doctors will check participants ALS and general health throughout the trial
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