AzTrials
AzTrials

Multiple SclerosisPhase 4STARTNCT01585298

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

A Phase 4 study testing FTY720 in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 258 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study evaluated bradycardiac events during first dose observation of fingolimod in MS patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
FTY720
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,998 participants
Where
258 sitesGermany
Study dates
29 Apr 2012to 12 Dec 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

258 sites in 1 country.

258 sites in 1 country

Germany258 sites

  • Novartis Investigative Site

    Aachen, 52062

  • Novartis Investigative Site

    Aachen, 52074

  • Novartis Investigative Site

    Aalen, 73430

  • Novartis Investigative Site

    Aalen-Wasseralfingen, 73433

  • Novartis Investigative Site

    Abensberg, 93326

  • Novartis Investigative Site

    Achim, 28832

  • Novartis Investigative Site

    Aichach, 86551

  • Novartis Investigative Site

    Altenburg, 04600

  • Novartis Investigative Site

    Altenholz-Stift, Germany, 24161

  • Novartis Investigative Site

    Alzenau in Unterfranken, 63755

  • Novartis Investigative Site

    Andernach, 56626

  • Novartis Investigative Site

    Asbach, 53567

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Augsburg, 86179

  • Novartis Investigative Site

    Bad Berka, 99437

  • Novartis Investigative Site

    Bad Hersfeld, 36251

  • Novartis Investigative Site

    Bad Homburg, 61348

  • Novartis Investigative Site

    Bad Honnef, 53604

  • Novartis Investigative Site

    Bad Krozingen, 79189

  • Novartis Investigative Site

    Bad Mergentheim, 97980

  • Novartis Investigative Site

    Bad Saarow, 15526

  • Novartis Investigative Site

    Bad Wildbad, 75323

  • Novartis Investigative Site

    Bamberg, 96052

  • Novartis Investigative Site

    Bayreuth, 95445

  • Novartis Investigative Site

    Berg, 82335

  • Novartis Investigative Site

    Bergisch Gladbach, 51429

  • Novartis Investigative Site

    Berlin, 10178

  • Novartis Investigative Site

    Berlin, 10365

  • Novartis Investigative Site

    Berlin, 10437

  • Novartis Investigative Site

    Berlin, 10713

  • Novartis Investigative Site

    Berlin, 120999

  • Novartis Investigative Site

    Berlin, 12101

  • Novartis Investigative Site

    Berlin, 12163

  • Novartis Investigative Site

    Berlin, 12351

  • Novartis Investigative Site

    Berlin, 12587

  • Novartis Investigative Site

    Berlin, 12621

  • Novartis Investigative Site

    Berlin, 13347

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, 13465

  • Novartis Investigative Site

    Berlin, 13507

  • Novartis Investigative Site

    Berlin, 14059

  • Novartis Investigative Site

    Berlin, 14163

  • Novartis Investigative Site

    Berlin, 14169

  • Novartis Investigative Site

    Bielefeld, 33602

  • Novartis Investigative Site

    Bielefeld, 33647

  • Novartis Investigative Site

    Böblingen, 71032

  • Novartis Investigative Site

    Bochum, 44787

  • Novartis Investigative Site

    Bochum, 44789

  • Novartis Investigative Site

    Bochum, 44791

  • Novartis Investigative Site

    Bochum, 44795

  • Novartis Investigative Site

    Bochum, 44869

  • Novartis Investigative Site

    Bogen, 94327

  • Novartis Investigative Site

    Bonn, 53111

  • Novartis Investigative Site

    Borna, 04552

  • Novartis Investigative Site

    Bottrop, 46236

  • Novartis Investigative Site

    Braunschweig, 38100

  • Novartis Investigative Site

    Braunschweig, 38114

  • Novartis Investigative Site

    Bremen, 28755

  • Novartis Investigative Site

    Bruchsal, 76646

  • Novartis Investigative Site

    Buchholz, 21244

  • Novartis Investigative Site

    Buchholz in der Nordheide, 21244

  • Novartis Investigative Site

    Butzbach, 35510

  • Novartis Investigative Site

    Celle, 29223

  • Novartis Investigative Site

    Chemnitz, 09117

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Cologne, 50674

  • Novartis Investigative Site

    Cologne, 50935

  • Novartis Investigative Site

    Cologne, 51109

  • Novartis Investigative Site

    Delbrück, 33129

  • Novartis Investigative Site

    Dessau, 06846

  • Novartis Investigative Site

    Dillingen, 66763

  • Novartis Investigative Site

    Dillingen, 89407

  • Novartis Investigative Site

    Dortmund, 44135

  • Novartis Investigative Site

    Dortmund, 44137

  • Novartis Investigative Site

    Dresden, 01067

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Düren, 52351

  • Novartis Investigative Site

    Düsseldorf, 40211

  • Novartis Investigative Site

    Düsseldorf, 40225

  • Novartis Investigative Site

    Düsseldorf, 40479

  • Novartis Investigative Site

    Düsseldorf, 40625

  • Novartis Investigative Site

    Eberswalde, 16225

  • Novartis Investigative Site

    Eisenach, 99817

  • Novartis Investigative Site

    Eisleben Lutherstadt, 06295

  • Novartis Investigative Site

    Eltville, 65343

  • Novartis Investigative Site

    Emden, 26721

  • Novartis Investigative Site

    Emmendingen, 79312

  • Novartis Investigative Site

    Erbach im Odenwald, 64711

  • Novartis Investigative Site

    Erfurt, 99089

  • Novartis Investigative Site

    Erfurt, 99096

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Eschwege, 37269

  • Novartis Investigative Site

    Essen, 45131

  • Novartis Investigative Site

    Essen, 45138

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Essen, 45257

  • Novartis Investigative Site

    Flensburg, Schleswig-Holstein, 24939

  • Novartis Investigative Site

    Frankfurt, 60313

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Frankfurt am Main, 60313

  • Novartis Investigative Site

    Frankfurt am Main, 60594

  • Novartis Investigative Site

    Freiburg im Breisgau, 79098

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Friedrichshafen, 88048

  • Novartis Investigative Site

    Fulda, 36037

  • Novartis Investigative Site

    Fulda, 36043

  • Novartis Investigative Site

    Gelnhausen, 63571

  • Novartis Investigative Site

    Gelsenkirchen, 45879

  • Novartis Investigative Site

    Gilching, 82205

  • Novartis Investigative Site

    Gladenbach, 35075

  • Novartis Investigative Site

    Göttingen, 37073

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Grevenbroich, 41515

  • Novartis Investigative Site

    Griesheim, 64347

  • Novartis Investigative Site

    Guelders, 47608

  • Novartis Investigative Site

    Gummersbach, 51643

  • Novartis Investigative Site

    Gütersloh, 33332

  • Novartis Investigative Site

    Haar, 85540

  • Novartis Investigative Site

    Hagen, 58095

  • Novartis Investigative Site

    Halle, 06120

  • Novartis Investigative Site

    Halle S, 06120

  • Novartis Investigative Site

    Hamburg, 20099

  • Novartis Investigative Site

    Hamburg, 20249

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hamburg, 22083

  • Novartis Investigative Site

    Hamburg, 22179

  • Novartis Investigative Site

    Hamburg, 22297

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    Hamburg, 22523

  • Novartis Investigative Site

    Hanover, 30161

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    Hanover, 30171

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Heidenheim, 89518

  • Novartis Investigative Site

    Herdecke, 58313

  • Novartis Investigative Site

    Herford, 32049

  • Novartis Investigative Site

    Herford, 32052

  • Novartis Investigative Site

    Hildesheim, 31134

  • Novartis Investigative Site

    Homburg, 66421

  • Novartis Investigative Site

    Hoppegarten, 15366

  • Novartis Investigative Site

    Ibbenbueren, 49477

  • Novartis Investigative Site

    Idar-Oberstein, 55743

  • Novartis Investigative Site

    Isselburg-Anholt, 46419

  • Novartis Investigative Site

    Itzehoe, 25524

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Jena, 07743

  • Novartis Investigative Site

    Jülich, 52428

  • Novartis Investigative Site

    Kaiserslautern, 67655

  • Novartis Investigative Site

    Kaltenkirchen, 24568

  • Novartis Investigative Site

    Kandel, 76870

  • Novartis Investigative Site

    Karlstadt am Main, 97753

  • Novartis Investigative Site

    Kassel, 34121

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Klingenmünster, 76889

  • Novartis Investigative Site

    Koeln-Longerich, 50737

  • Novartis Investigative Site

    Königsbrück, 01936

  • Novartis Investigative Site

    Korbach, 34497

  • Novartis Investigative Site

    Krefeld, 47800

  • Novartis Investigative Site

    Krefeld, 47805

  • Novartis Investigative Site

    Landshut, 84028

  • Novartis Investigative Site

    Lappersdorf, 93138

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leipzig, 04157

  • Novartis Investigative Site

    Leipzig, 04275

  • Novartis Investigative Site

    Leipzig, 04299

  • Novartis Investigative Site

    Leverkusen, 51375

  • Novartis Investigative Site

    Lohr a. Main, 79816

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Ludwigshafen, 67059

  • Novartis Investigative Site

    Ludwigshafen, 67063

  • Novartis Investigative Site

    Lüneburg, 21335

  • Novartis Investigative Site

    Lünen, 44534

  • Novartis Investigative Site

    Magdeburg, 39104

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    Magdeburg, 39120

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    Mannheim, 66163

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    Mannheim, 68159

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    Mannheim, 68161

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    Marburg, 35039

  • Novartis Investigative Site

    Meisenheim, 55590

  • Novartis Investigative Site

    Minden, 32423

  • Novartis Investigative Site

    Minden, 32429

  • Novartis Investigative Site

    Mittweida, 09648

  • Novartis Investigative Site

    Mönchengladbach, 41063

  • Novartis Investigative Site

    Mönchengladbach, 41239

  • Novartis Investigative Site

    Mosbach, 74821

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    Mülheim, 45481

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    München, 80331

  • Novartis Investigative Site

    München, 81675

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    München, 81829

  • Novartis Investigative Site

    Munich, Bavaria, 81241

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    Münster, 48147

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    Münster, 48149

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    Nagold, 72202

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    Naumburg, 06618

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    Neu-Ulm, 89231

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    Neuburg an der Donau, 86633

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    Neuruppin, 16816

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    Neusäß, 86356

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    Neustadt an der Weinstraße, 67433

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    Nordhausen, 99734

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    Nuremberg, 90461

  • Novartis Investigative Site

    Offenbach, 63069

  • Novartis Investigative Site

    Öhringen, 74613

  • Novartis Investigative Site

    Oldenburg, 26122

  • Novartis Investigative Site

    Oldenburg I. Holstein, 23758

  • Novartis Investigative Site

    Osnabrück, 49074

  • Novartis Investigative Site

    Osnabrück, 49076

  • Novartis Investigative Site

    Osnabrück, 49078

  • Novartis Investigative Site

    Ostfildern, Baden-Wurttemberg, 73760

  • Novartis Investigative Site

    Paderborn, 33098

  • Novartis Investigative Site

    Papenburg, 26871

  • Novartis Investigative Site

    Pforzheim, 75172

  • Novartis Investigative Site

    Potsdam, 14471

  • Novartis Investigative Site

    Prien am Chiemsee, 83209

  • Novartis Investigative Site

    Quakenbrück, 49610

  • Novartis Investigative Site

    Querfurt, 06268

  • Novartis Investigative Site

    Ravensburg, 88212

  • Novartis Investigative Site

    Recklinghausen, 45657

  • Novartis Investigative Site

    Regensburg, 93059

  • Novartis Investigative Site

    Remscheid, 42853

  • Novartis Investigative Site

    Rostock, 18057

  • Novartis Investigative Site

    Rüdersdorf, 15562

  • Novartis Investigative Site

    Saarbrücken, 66113

  • Novartis Investigative Site

    Saint Ingbert, 66386

  • Novartis Investigative Site

    Sande, 26452

  • Novartis Investigative Site

    Schwalmstadt-Treysa, 34613

  • Novartis Investigative Site

    Schwerin, 19057

  • Novartis Investigative Site

    Siegen, 57076

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    Singen, 78224

  • Novartis Investigative Site

    Sinsheim, 74889

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    Solingen, 42719

  • Novartis Investigative Site

    Stade, 21682

  • Novartis Investigative Site

    Stadtroda, 07646

  • Novartis Investigative Site

    Stralsund, 18439

  • Novartis Investigative Site

    Stuttgart, 70174

  • Novartis Investigative Site

    Stuttgart, 70176

  • Novartis Investigative Site

    Stuttgart, 70178

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    Stuttgart, 70182

  • Novartis Investigative Site

    Telgte, 48291

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    Teupitz, 15755

  • Novartis Investigative Site

    Troisdorf, 53844

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Ulm, 89073

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    Ulm, 89081

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    Unterhaching, 82008

  • Novartis Investigative Site

    Wasserburg, 83512

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    Wendlingen, 73240

  • Novartis Investigative Site

    Wermsdorf, 04779

  • Novartis Investigative Site

    Westerstede, 26655

  • Novartis Investigative Site

    Westerstede/Oldenburg, 26655

  • Novartis Investigative Site

    Wiesbaden, 65183

  • Novartis Investigative Site

    Wiesbaden, 65191

  • Novartis Investigative Site

    Wolfratshausen, 82515

  • Novartis Investigative Site

    Wuppertal, 42103

  • Novartis Investigative Site

    Wuppertal, 42283

  • Novartis Investigative Site

    Würzburg, 97070

  • Novartis Investigative Site

    Würzburg, 97080

  • Novartis Investigative Site

    Zwickau, 08060

Other trials in Germany

About this study

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

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

Being tested
FTY720
Keywords
Multiple Sclerosis, MS, Fingolimod, Gilenya, ECG, Bradyarrythmia, conduction abnormalities, first dose observation
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FTY720Drug

    Also called 0.5 mg gelatin capsules

Study groups in NCT01585298
Study groupRoleWhat they receive
FingolimodExperimentalFingolimod 0.5 mg by mouth once daily for 7 days.
Receives: Drug: FTY720

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, during 6 hour monitoring post first dose observation

  2. 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

    Measured: baseline during 6 hour monitoring post dose

Secondary outcomes (3)

  1. 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.

    Measured: baseline post-dose

  2. 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.

    Measured: up to day 7

  3. 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.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2012 (estimated)
  2. Study start29 Apr 2012
  3. Primary completion12 Dec 2016
  4. Study completion12 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6,998 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01585298
Sponsor's protocol ID
CFTY720DDE17
Acronym
START
Status last verified
Aug 2019
First submitted
23 Apr 2012
Last updated
23 Sep 2019
Data monitoring committee
Yes

Publications

  • Limmroth V, Ziemssen T, Lang M, Richter S, Wagner B, Haas J, Schmidt S, Gerbershagen K, Lassek C, Klotz L, Hoffmann O, Albert C, Schuh K, Baier-Ebert M, Wendt G, Schieb H, Hoyer S, Dechend R, Haverkamp W. Electrocardiographic assessments and cardiac events after fingolimod first dose - a comprehensive monitoring study. BMC Neurol. 2017 Jan 18;17(1):11. doi: 10.1186/s12883-016-0789-7.

    PubMed 28100182

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FTY720 in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 258 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 258 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With 2nd or 3rd Degree Atrioventricular (AV) Block (time frame: baseline, during 6 hour monitoring post first dose observation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01585298, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.

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