STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)

Multiple Sclerosis Clinical Trial

— START  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585298
• Other study ID #: CFTY720DDE17
• Status: Completed
• Phase: Phase 4
• Start date: April 29, 2012
• Est. completion date: December 12, 2016

Study information

• Verified date: August 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluated bradycardiac events during first dose observation of fingolimod in MS patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6998
• Est. completion date: December 12, 2016
• Est. primary completion date: December 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• FTY720

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Aalen
Germany	Novartis Investigative Site	Aalen-Wasseralfingen
Germany	Novartis Investigative Site	Abensberg
Germany	Novartis Investigative Site	Achim
Germany	Novartis Investigative Site	Aichach
Germany	Novartis Investigative Site	Altenburg
Germany	Novartis Investigative Site	Altenholz-Stift
Germany	Novartis Investigative Site	Alzenau
Germany	Novartis Investigative Site	Andernach
Germany	Novartis Investigative Site	Asbach
Germany	Novartis Investigative Site	Aschaffenburg
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bad Berka
Germany	Novartis Investigative Site	Bad Hersfeld
Germany	Novartis Investigative Site	Bad Homburg
Germany	Novartis Investigative Site	Bad Honnef
Germany	Novartis Investigative Site	Bad Krozingen
Germany	Novartis Investigative Site	Bad Mergentheim
Germany	Novartis Investigative Site	Bad Saarow
Germany	Novartis Investigative Site	Bad Wildbad
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Bayreuth
Germany	Novartis Investigative Site	Berg
Germany	Novartis Investigative Site	Bergisch Gladbach
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Boblingen
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bogen
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Borna
Germany	Novartis Investigative Site	Bottrop
Germany	Novartis Investigative Site	Braunschweig
Germany	Novartis Investigative Site	Braunschweig
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Bruchsal
Germany	Novartis Investigative Site	Buchholz
Germany	Novartis Investigative Site	Buchholz in der Nordheide
Germany	Novartis Investigative Site	Butzbach
Germany	Novartis Investigative Site	Celle
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Delbrueck
Germany	Novartis Investigative Site	Dessau
Germany	Novartis Investigative Site	Dillingen
Germany	Novartis Investigative Site	Dillingen
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Düren
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Eberswalde
Germany	Novartis Investigative Site	Eisenach
Germany	Novartis Investigative Site	Eltville
Germany	Novartis Investigative Site	Emden
Germany	Novartis Investigative Site	Emmendingen
Germany	Novartis Investigative Site	Erbach
Germany	Novartis Investigative Site	Erfurt
Germany	Novartis Investigative Site	Erfurt
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Eschwege
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Flensburg	Schleswig Holstein
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt am Main
Germany	Novartis Investigative Site	Frankfurt am Main
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Friedrichshafen
Germany	Novartis Investigative Site	Fulda
Germany	Novartis Investigative Site	Fulda
Germany	Novartis Investigative Site	Geldern
Germany	Novartis Investigative Site	Gelnhausen
Germany	Novartis Investigative Site	Gelsenkirchen
Germany	Novartis Investigative Site	Gilching
Germany	Novartis Investigative Site	Gladenbach
Germany	Novartis Investigative Site	Gottingen
Germany	Novartis Investigative Site	Göttingen
Germany	Novartis Investigative Site	Greifswald
Germany	Novartis Investigative Site	Grevenbroich
Germany	Novartis Investigative Site	Griesheim
Germany	Novartis Investigative Site	Guetersloh
Germany	Novartis Investigative Site	Gummersbach
Germany	Novartis Investigative Site	Haar
Germany	Novartis Investigative Site	Hagen
Germany	Novartis Investigative Site	Halle (Saale)
Germany	Novartis Investigative Site	Halle S
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Heidenheim
Germany	Novartis Investigative Site	Herdecke
Germany	Novartis Investigative Site	Herford
Germany	Novartis Investigative Site	Herford
Germany	Novartis Investigative Site	Hildesheim
Germany	Novartis Investigative Site	Homburg
Germany	Novartis Investigative Site	Hoppegarten
Germany	Novartis Investigative Site	Ibbenbueren
Germany	Novartis Investigative Site	Idar-Oberstein
Germany	Novartis Investigative Site	Isselburg-Anholt
Germany	Novartis Investigative Site	Itzehoe
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Juelich
Germany	Novartis Investigative Site	Kaiserslautern
Germany	Novartis Investigative Site	Kaltenkirchen
Germany	Novartis Investigative Site	Kandel
Germany	Novartis Investigative Site	Karlstadt
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Klingenmünster
Germany	Novartis Investigative Site	Koeln	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln-Longerich
Germany	Novartis Investigative Site	Koln
Germany	Novartis Investigative Site	Köln
Germany	Novartis Investigative Site	Königsbrück
Germany	Novartis Investigative Site	Korbach
Germany	Novartis Investigative Site	Krefeld
Germany	Novartis Investigative Site	Krefeld
Germany	Novartis Investigative Site	Landshut
Germany	Novartis Investigative Site	Lappersdorf
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leverkusen
Germany	Novartis Investigative Site	Lohr am Main
Germany	Novartis Investigative Site	Lubeck
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Luenen
Germany	Novartis Investigative Site	Luneburg
Germany	Novartis Investigative Site	Lutherstadt Eisleben
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Meisenheim
Germany	Novartis Investigative Site	Minden
Germany	Novartis Investigative Site	Minden
Germany	Novartis Investigative Site	Mittweida
Germany	Novartis Investigative Site	Mönchengladbach
Germany	Novartis Investigative Site	Mönchengladbach
Germany	Novartis Investigative Site	Mosbach
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Mülheim
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Munich	Bavaria
Germany	Novartis Investigative Site	Münster
Germany	Novartis Investigative Site	Nagold
Germany	Novartis Investigative Site	Naumburg
Germany	Novartis Investigative Site	Neu-Ulm
Germany	Novartis Investigative Site	Neuburg an der Donau
Germany	Novartis Investigative Site	Neuruppin
Germany	Novartis Investigative Site	Neusaess
Germany	Novartis Investigative Site	Neustadt An Der Weinstraße
Germany	Novartis Investigative Site	Nordhausen
Germany	Novartis Investigative Site	Nürnberg
Germany	Novartis Investigative Site	Offenbach
Germany	Novartis Investigative Site	Öhringen
Germany	Novartis Investigative Site	Oldenburg
Germany	Novartis Investigative Site	Oldenburg I. Holstein
Germany	Novartis Investigative Site	Osnabrück
Germany	Novartis Investigative Site	Osnabrück
Germany	Novartis Investigative Site	Osnabrück
Germany	Novartis Investigative Site	Osnabrueck
Germany	Novartis Investigative Site	Ostfildern	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Paderborn
Germany	Novartis Investigative Site	Papenburg
Germany	Novartis Investigative Site	Pforzheim
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Prien
Germany	Novartis Investigative Site	Quakenbrueck
Germany	Novartis Investigative Site	Querfurt
Germany	Novartis Investigative Site	Ravensburg
Germany	Novartis Investigative Site	Recklinghausen
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Remscheid
Germany	Novartis Investigative Site	Rostock
Germany	Novartis Investigative Site	Rüdersdorf
Germany	Novartis Investigative Site	Saarbruecken
Germany	Novartis Investigative Site	Saint Ingbert
Germany	Novartis Investigative Site	Sande
Germany	Novartis Investigative Site	Schwalmstadt-Treysa
Germany	Novartis Investigative Site	Schwerin
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Singen
Germany	Novartis Investigative Site	Sinsheim
Germany	Novartis Investigative Site	Solingen
Germany	Novartis Investigative Site	Stade
Germany	Novartis Investigative Site	Stadtroda
Germany	Novartis Investigative Site	Stralsund
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Telgte
Germany	Novartis Investigative Site	Teupitz
Germany	Novartis Investigative Site	Troisdorf
Germany	Novartis Investigative Site	Tübingen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Unterhaching
Germany	Novartis Investigative Site	Wasserburg
Germany	Novartis Investigative Site	Wendlingen
Germany	Novartis Investigative Site	Wermsdorf
Germany	Novartis Investigative Site	Westerstede
Germany	Novartis Investigative Site	Westerstede/Oldenburg
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Wolfratshausen
Germany	Novartis Investigative Site	Wuppertal
Germany	Novartis Investigative Site	Wuppertal
Germany	Novartis Investigative Site	Würzburg
Germany	Novartis Investigative Site	Würzburg
Germany	Novartis Investigative Site	Zwickau

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With 2nd or 3rd Degree Atrioventricular (AV) Block	AV Blocks/Heart block is an abnormal heart rhythm where the heart beats too slowly; the electrical signals that tell the heart to contract are partially intermittent (Type 2:1) or slowed (1st and 2nd degree) or blocked (3rd degree) between the upper chambers (atria) and the lower chambers (ventricles). In 2nd degree AV Blocks, electrical impulses are intermittent (type 2:1) or delayed w/ each subsequent heartbeat (Mobitz type I) until a beat fails to reach the ventricles entirely. This type of block often is physiologic and observed in a highly relaxed state & during sleep. In 2nd degree AV Blocks type II, the atria electrical impulses are unable to reach the ventricles, a more serious condition. In 3rd degree AV Blocks (complete heart block), none of the electrical impulses reach either the atria or the ventricles. Patients can experience simultaneously both types of 2nd or 3rd degree AV Blocks without any symptoms.	baseline, during 6 hour monitoring post first dose observation
Primary	Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM)	Number of patients with heart rate below 45 beats bpm in ECG during first dose observation	baseline during 6 hour monitoring post dose
Secondary	Number of Participants With Prolonged QTc Interval (Friderica)	Number of patients with conduction abnormalities such as QT prolongation, first degree AV block during treatment initiation.; The QT interval is a period between the activation and the regeneration of ventricular contraction. A prolonged QT interval can be a potential marker of cardiac arrhythmias.; Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients.	baseline post-dose
Secondary	Number of Participants With Bradyarrhythmic Electrocardiogram (ECG) Events	The number of participants with bradyarrhythmic electrocardiogram (ECG) events was assessed. Bradyarrhythmic ECG events are defined as QTc Fridericia time > 450 ms for males and > 470 ms for females.	up to day 7
Secondary	Number of Patients With Cardiac Adverse Events	The number of participants with the occurrence of subsequent cardiac adverse events (AEs) and serious cardiac AEs during study was assessed. Cardiac events were defined as the following Medical Dictionary for Regulatory Activities (MedDRA) preferred terms: angina pectoris, chest discomfort, dizziness, dyspnoea, dyspnoea exertional, fatigue, palpitations, syncope, vertigo, vertigo positional and vision blurred.	7 days