Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441617
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
Sponsor:
Accelerated Cure Project for Multiple Sclerosis
Organization:
Accelerated Cure Project for Multiple Sclerosis
Study Overview
Official Title:
Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
CAFE-MS
Brief Summary:
CAFE-MS will assess the effectiveness of two online programs for fatigue in multiple sclerosis MS Although they differ both of these online programs contain information about MS and fatigue intended to help people with MS understand and manage their fatigue
This large-scale decentralized clinical trial is projected to enroll 2000 people with MS The collaboration between iConquerMS and 5 Veterans Affairs VA sites in the MS Centers of Excellence is designed to ensure sufficient representation of people with MS from populations traditionally under-represented in MS clinical trials
The study is a 3-arm randomized controlled clinical trial with study participation lasting 1 year Two of the trial arms will include one of two online programs for managing fatigue in MS added to the trial participants usual MS treatment and the third arm will include usual MS treatment alone The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial
This large-scale decentralized clinical trial is projected to enroll 2000 people with MS The collaboration between iConquerMS and 5 Veterans Affairs VA sites in the MS Centers of Excellence is designed to ensure sufficient representation of people with MS from populations traditionally under-represented in MS clinical trials
The study is a 3-arm randomized controlled clinical trial with study participation lasting 1 year Two of the trial arms will include one of two online programs for managing fatigue in MS added to the trial participants usual MS treatment and the third arm will include usual MS treatment alone The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDMRP- MS220136 | OTHER_GRANT | Congressionally Directed Medical Research Programs CDMRP | None |