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A 1-week, Open-label, Multi-center Study to Explore Conduction Abnormalities During First Dose Administration of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
Results by group
Participants With 2nd or 3rd Degree Atrioventricular (AV) Block
baseline, during 6 hour monitoring post first dose observation
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod | 120 Participants | 6998 | |
| Fingolimod | 117 Participants | 6998 | |
| Fingolimod | 0 Participants | 6998 | |
| Fingolimod | 43 Participants | 6998 | |
| Fingolimod | 1 Participants | 6998 |
Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM)
baseline during 6 hour monitoring post dose
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod | 63 Participants | 6998 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fingolimod | 6998 | 160 (2.3%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Participants With 2nd or 3rd Degree Atrioventricular (AV) Block
baseline, during 6 hour monitoring post first dose observation
Mood and sleepNumber of Patients With Heart Rate Below 45 Beats Per Minute (BPM)
baseline during 6 hour monitoring post dose
Other measures (3)
Number of Participants With Prolonged QTc Interval (Friderica)
baseline post-dose
SafetyNumber of Participants With Bradyarrhythmic Electrocardiogram (ECG) Events
up to day 7
Number of Patients With Cardiac Adverse Events
7 days
VisionFatigueSafety
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
Key Inclusion Criteria: * Subjects with relapsing remitting MS. * Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy. * Patients who had been previously on 2nd line therapies. It was understood that these patients satisfied the above mentioned criteria listed under a. in the past. This also included patients, who were previously treated with fingolimod (regardless of whether or not they had already been treated within the START study) but discontinued treatment due to medical reasons. - or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI). Key Exclusion Criteria: * immunocompromised patients * active infections * pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception * presence of malignancy (other than localized basal cell carcinoma of the skin).
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study evaluated bradycardiac events during first dose observation of fingolimod in MS patients.
Papers
Loading reviews and guidelines…
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History
Started
Apr 2012
Main results due
Dec 2016
Finished
Dec 2016
Results posted
Sept 2019