Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527222
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-04-25
Brief Title:
A Study of Ranolazine in ALS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ranolazine in ALS Safety and Effect on Cramps Function and Quality of Life
Status:
NOT_YET_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:
None
Brief Summary:
The purpose of this study is to evaluate safety effect on cramps function and quality of life of ranolazine versus placebo for the treatment of ALS
Detailed Description:
A prospective multi center double-blind placebo-controlled parallel group study of 2 doses of ranolazine 500 mg and 1000 mg twice daily compared to placebo in patients with ALS
Approximately 72 adults with ALS will be enrolled into the study in the United States at approximately 7 ALS treatment sites
Participants will take oral ranolazine or placebo twice daily attend a minimum of 5 onsite research visits and 4 remote research visits
The study is estimated to last 28 weeks for each participant
Approximately 72 adults with ALS will be enrolled into the study in the United States at approximately 7 ALS treatment sites
Participants will take oral ranolazine or placebo twice daily attend a minimum of 5 onsite research visits and 4 remote research visits
The study is estimated to last 28 weeks for each participant
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