EXPER-CA/IL
What it found
The trial ended early for another reason (see below).
Reason given: Sponsor Decision
This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Diroximel fumarate
Kelch-like ECH-associated protein 1 inhibitor
What it measured
Main measures
Percentage of Participants on Treatment with DRF
Year 1
Other measures (16)
Percentage of Participants on Treatment with DRF
Month 3
Percentage of Participants on Treatment with DRF
Year 2
Annualized Relapse Rate (ARR) with DRF
Year 1 and 2
RelapsesPercentage of Participants Relapsed
Year 1 and 2
RelapsesChange in Cognitive Processing Speed Test (CPST) Score
Baseline, Year 1 and 2
Thinking and memoryChange in Score for Each Domain of Quality of Life in Neurological Disorders (Neuro- QoL™) Questionnaire
Baseline, Year 1 and 2
Quality of life (reported by participants)Change in Disability, as Measured by Expanded Disability Status Scale (EDSS)
Baseline, Year 1 and 2
Disability progressionMean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Score
Baseline, Year 1 and 2
Quality of life (reported by participants)SafetyNumber of Participants with Gastrointestinal (GI) Adverse Events (AEs)
Up to Month 32
SafetyNumber of Participants with AEs Leading to Treatment Discontinuation
Up to Month 32
Who could take part
Relapsing and progressive · 18 and over
Key Inclusion Criteria: * Have a diagnosis of MS and satisfy the approved therapeutic indication for DRF per the prescribing information. * DRF prescribed and planned to be initiated within 60 days of enrollment or already initiated, with enrollment occurring no more than 7 days since the first dose. Key Exclusion Criteria: * History of gastric bypass or required use of feeding tubes. * Current enrollment in any interventional study or in any study which may conflict with this study, per the discretion of the principal investigator (PI) and Biogen * Have received prior treatment with DRF (more than 7 days before enrollment). NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (RMS) treated with diroximel fumarate (DRF) in routine clinical practice. The secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term persistence on treatment; to assess the effect of DRF on relapses; to assess the impact of DRF on cognition; to assess the impact of DRF on participant reported outcomes (PROs); to assess the impact of DRF on disability; to assess treatment satisfaction with DRF; to explore the real-world safety profile of DRF (i.e., gastrointestinal [GI] tolerability, lymphocyte dynamics, adverse events [AEs] leading to discontinuation, and serious adverse events [SAEs].
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History
Started
Dec 2021
Main results due
Apr 2023
Finished
Apr 2023
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