Phase 4
N=6,998
STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01585298 ↗Enrolled (actual)
6,998
Serious AEs
2.3%
Results posted
Sep 2019
Primary outcome: Primary: Participants With 2nd or 3rd Degree Atrioventricular (AV) Block — 120; 117; 0; 43 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- FTY720 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With 2nd or 3rd Degree Atrioventricular (AV) Block |
120; 117; 0; 43; 1 | — |
| PRIMARY Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM) |
63 | — |
| SECONDARY Number of Participants With Prolonged QTc Interval (Friderica) |
7; 6 | — |
| SECONDARY Number of Participants With Bradyarrhythmic Electrocardiogram (ECG) Events |
26 | — |
| SECONDARY Number of Patients With Cardiac Adverse Events |
489; 9 | — |
Summary
This study evaluated bradycardiac events during first dose observation of fingolimod in MS patients.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01585298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.