Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360906
Status:
COMPLETED
Last Update Posted:
2006-08-07
First Post:
2006-08-04
Brief Title:
Omega-3 Fatty Acid Treatment in Multiple Sclerosis
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
Omega-3 Fatty Acid Treatment in Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2006-08
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:
None
Brief Summary:
Based on previous clinical studies indicating beneficial treatment effects of omega-3 fatty acids in multiple sclerosis and the increasing evidence of anti-inflammatory effects of omega-3 fatty acids this study aims to evaluate treatment effects of concentrated omega-3 fatty acids Triomar in MS both as monotherapy and in combination with standard immunomodulatory therapy defined as interferon-beta 1a Rebif
Detailed Description:
Patients with relapsing-remitting multiple sclerosis with evidence of disease activity defined as at least one relapse or at least one new MRI lesion during the year prior to inclusion will be included in the study
Eligible patients will be randomised for daily treatment with either oral omega-3 fatty acid Triomar or placebo After six months all patients will in addition receive interferon-beta 1a Rebif 44 mcg subcutaneous three times per week for another 18 months
The patients will undergo monthly contrast enhanced MRI for the first nine months and thereafter at months 12 and 24 They will also be examined by clinical and laboratory tests at six months intervals in addition to month 9 3 months after start of IFNB treatment Fatigue and QoL registration will be performed at baseline and at months 6 12 and 24 Tests for circulating neutralising antibodies against interferon-beta will be performed during the study
Eligible patients will be randomised for daily treatment with either oral omega-3 fatty acid Triomar or placebo After six months all patients will in addition receive interferon-beta 1a Rebif 44 mcg subcutaneous three times per week for another 18 months
The patients will undergo monthly contrast enhanced MRI for the first nine months and thereafter at months 12 and 24 They will also be examined by clinical and laboratory tests at six months intervals in addition to month 9 3 months after start of IFNB treatment Fatigue and QoL registration will be performed at baseline and at months 6 12 and 24 Tests for circulating neutralising antibodies against interferon-beta will be performed during the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OFAMS REK VEST 00504 | None | None | None |