No registrations found.
ID
Source
Brief title
Health condition
Patients with Relapsing Remittent Multiple Sclerosis
Sponsors and support
Gooimeer 10, 1411 DD Naarden,The Netherlands
Intervention
Outcome measures
Primary outcome
Change in cognitive status from baseline to 36 months, measured by the Brief Repeatable Battery – Neuropsychological (BRB-N)
Secondary outcome
• change in cognitive status measured by the BRB-N from baseline to month 12 and 24
• change in mood measured by the HADS from baseline to month 12 – 24 – 36
• change in fatigue measured by the MFIS from baseline to month 12 – 24 – 36
• change in QoL measured by MSIS-29 from baseline to month 12 – 24 – 36
• Pairwise Correlation within the time points baseline – M12 – M24 – M36 between:
o Cognitive status and mood
o Cognitive status and fatigue
o Cognitive status and Quality of Life
• (serious) Adverse events
Study objective
To characterize the effect of Aubagio on the Cognitive status, measured by the Brief Repeatable Battery – neuropsychological (BRB-N battery) in RRMS patients
Study design
Estimated enrolment duration: 18 months
Estimated date for first patient in (FPI): Q3 2016
Estimated Last Patient In (LPI): Q1 2018
Estimated Last Patient Last Visit (LPLV): Q1 2021
Database lock: Q2 2021
Publication: Q3 2021
Intervention
none
R. Hupperts
Sittard 6130 MB
The Netherlands
R. Hupperts
Sittard 6130 MB
The Netherlands
Inclusion criteria
• Patients with RRMS according the McDonald criteria 2010 and approved SmPC of Aubagio
• Treatment naïve RRMS patients or currently being treated with Aubagio for no more than 2 month or previously treated (with other first-line DMDs) with a wash-out period according to the respective SmPC before starting Aubagio. (verification has occurred prior to study enrollment)
• EDSS score ≤ 4
• Patients who are willing and able to sign written consent
Exclusion criteria
Severe disability and/or any neurological or severe psychiatric disorder, history of alcohol/ drugs abuse, history of traumatic brain injury with residual symptoms which might interfere with cognitive performance and other questionnaire outcomes
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5804 |
| NTR-old | NTR5959 |
| Other | : TERIFL07828 |