Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170970
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-12-06
Brief Title:
Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness
Status:
RECRUITING
Status Verified Date:
2024-06
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:
SOLARIMS
Brief Summary:
Fatigue is a prevalent and disabling symptom in Multiple Sclerosis MS affecting up to 90 of patients Current treatments including off-label prescriptions of wake-promoting agents have shown limited effectiveness Previous research indicates that these agents may be beneficial specifically for MS patients with concomitant excessive daytime sleepiness This study uses a randomized double-blind placebo-controlled crossover design Participants will undergo a 10-day lead-in with he medicationplacebo followed by two four-week treatment periods separated by a one-week washout Outcomes will be measured primarily using the Modified Fatigue Impact Scale MFIS with additional exploratory measures collected via a smartphone app that assesses fatigue through keystroke dynamics This novel approach to fatigue measurement aims to capture real-time variations and provide more granular data than traditional self-report questionnaires
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?:
None