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

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

FTY720

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, MS, Fingolimod, Gilenya, ECG, Bradyarrythmia, conduction abnormalities, first dose observation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fingolimod

Arm Description

Fingolimod 0.5 mg by mouth once daily for 7 days.

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01585298

First Posted

April 23, 2012

Last Updated

August 21, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01585298

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

April 29, 2012 (Actual)

Primary Completion Date

December 12, 2016 (Actual)

Study Completion Date

December 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple Sclerosis, MS, Fingolimod, Gilenya, ECG, Bradyarrythmia, conduction abnormalities, first dose observation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6998 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fingolimod

Arm Type

Experimental

Arm Description

Fingolimod 0.5 mg by mouth once daily for 7 days.

Intervention Type

Drug

Intervention Name(s)

FTY720

Other Intervention Name(s)

0.5 mg gelatin capsules

Primary Outcome Measure Information:

Title

Participants With 2nd or 3rd Degree Atrioventricular (AV) Block

Description

Time Frame

baseline, during 6 hour monitoring post first dose observation

Title

Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM)

Description

Number of patients with heart rate below 45 beats bpm in ECG during first dose observation

Time Frame

baseline during 6 hour monitoring post dose

Secondary Outcome Measure Information:

Title

Number of Participants With Prolonged QTc Interval (Friderica)

Description

Time Frame

baseline post-dose

Title

Number of Participants With Bradyarrhythmic Electrocardiogram (ECG) Events

Description

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.

Time Frame

up to day 7

Title

Number of Patients With Cardiac Adverse Events

Description

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Ostfildern

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

73760

Country

Germany

Facility Name

Novartis Investigative Site

City

Munich

State/Province

Bavaria

ZIP/Postal Code

81241

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Flensburg

State/Province

Schleswig Holstein

ZIP/Postal Code

24939

Country

Germany

Facility Name

Novartis Investigative Site

City

Aachen

ZIP/Postal Code

52062

Country

Germany

Facility Name

Novartis Investigative Site

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Novartis Investigative Site

City

Aalen-Wasseralfingen

ZIP/Postal Code

73433

Country

Germany

Facility Name

Novartis Investigative Site

City

Aalen

ZIP/Postal Code

73430

Country

Germany

Facility Name

Novartis Investigative Site

City

Abensberg

ZIP/Postal Code

93326

Country

Germany

Facility Name

Novartis Investigative Site

City

Achim

ZIP/Postal Code

28832

Country

Germany

Facility Name

Novartis Investigative Site

City

Aichach

ZIP/Postal Code

86551

Country

Germany

Facility Name

Novartis Investigative Site

City

Altenburg

ZIP/Postal Code

04600

Country

Germany

Facility Name

Novartis Investigative Site

City

Altenholz-Stift

ZIP/Postal Code

24161

Country

Germany

Facility Name

Novartis Investigative Site

City

Alzenau

ZIP/Postal Code

63755

Country

Germany

Facility Name

Novartis Investigative Site

City

Andernach

ZIP/Postal Code

56626

Country

Germany

Facility Name

Novartis Investigative Site

City

Asbach

ZIP/Postal Code

53567

Country

Germany

Facility Name

Novartis Investigative Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Novartis Investigative Site

City

Augsburg

ZIP/Postal Code

86179

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Berka

ZIP/Postal Code

99437

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Hersfeld

ZIP/Postal Code

36251

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Homburg

ZIP/Postal Code

61348

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Honnef

ZIP/Postal Code

53604

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Krozingen

ZIP/Postal Code

79189

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Mergentheim

ZIP/Postal Code

97980

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Saarow

ZIP/Postal Code

15526

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Wildbad

ZIP/Postal Code

75323

Country

Germany

Facility Name

Novartis Investigative Site

City

Bamberg

ZIP/Postal Code

96052

Country

Germany

Facility Name

Novartis Investigative Site

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Novartis Investigative Site

City

Bergisch Gladbach

ZIP/Postal Code

51429

Country

Germany

Facility Name

Novartis Investigative Site

City

Berg

ZIP/Postal Code

82335

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10178

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10365

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10437

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10713

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

120999

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12101

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12163

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12351

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12587

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12621

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13347

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13465

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13507

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14163

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14169

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33602

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33647

Country

Germany

Facility Name

Novartis Investigative Site

City

Boblingen

ZIP/Postal Code

71032

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44789

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44795

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44869

Country

Germany

Facility Name

Novartis Investigative Site

City

Bogen

ZIP/Postal Code

94327

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53111

Country

Germany

Facility Name

Novartis Investigative Site

City

Borna

ZIP/Postal Code

04552

Country

Germany

Facility Name

Novartis Investigative Site

City

Bottrop

ZIP/Postal Code

46236

Country

Germany

Facility Name

Novartis Investigative Site

City

Braunschweig

ZIP/Postal Code

38100

Country

Germany

Facility Name

Novartis Investigative Site

City

Braunschweig

ZIP/Postal Code

38114

Country

Germany

Facility Name

Novartis Investigative Site

City

Bremen

ZIP/Postal Code

28755

Country

Germany

Facility Name

Novartis Investigative Site

City

Bruchsal

ZIP/Postal Code

76646

Country

Germany

Facility Name

Novartis Investigative Site

City

Buchholz in der Nordheide

ZIP/Postal Code

21244

Country

Germany

Facility Name

Novartis Investigative Site

City

Buchholz

ZIP/Postal Code

21244

Country

Germany

Facility Name

Novartis Investigative Site

City

Butzbach

ZIP/Postal Code

35510

Country

Germany

Facility Name

Novartis Investigative Site

City

Celle

ZIP/Postal Code

29223

Country

Germany

Facility Name

Novartis Investigative Site

City

Chemnitz

ZIP/Postal Code

09117

Country

Germany

Facility Name

Novartis Investigative Site

City

Delbrueck

ZIP/Postal Code

33129

Country

Germany

Facility Name

Novartis Investigative Site

City

Dessau

ZIP/Postal Code

06846

Country

Germany

Facility Name

Novartis Investigative Site

City

Dillingen

ZIP/Postal Code

66763

Country

Germany

Facility Name

Novartis Investigative Site

City

Dillingen

ZIP/Postal Code

89407

Country

Germany

Facility Name

Novartis Investigative Site

City

Dortmund

ZIP/Postal Code

44135

Country

Germany

Facility Name

Novartis Investigative Site

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01067

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

ZIP/Postal Code

40479

Country

Germany

Facility Name

Novartis Investigative Site

City

Düren

ZIP/Postal Code

52351

Country

Germany

Facility Name

Novartis Investigative Site

City

Düsseldorf

ZIP/Postal Code

40211

Country

Germany

Facility Name

Novartis Investigative Site

City

Düsseldorf

ZIP/Postal Code

40625

Country

Germany

Facility Name

Novartis Investigative Site

City

Eberswalde

ZIP/Postal Code

16225

Country

Germany

Facility Name

Novartis Investigative Site

City

Eisenach

ZIP/Postal Code

99817

Country

Germany

Facility Name

Novartis Investigative Site

City

Eltville

ZIP/Postal Code

65343

Country

Germany

Facility Name

Novartis Investigative Site

City

Emden

ZIP/Postal Code

26721

Country

Germany

Facility Name

Novartis Investigative Site

City

Emmendingen

ZIP/Postal Code

79312

Country

Germany

Facility Name

Novartis Investigative Site

City

Erbach

ZIP/Postal Code

64711

Country

Germany

Facility Name

Novartis Investigative Site

City

Erfurt

ZIP/Postal Code

99089

Country

Germany

Facility Name

Novartis Investigative Site

City

Erfurt

ZIP/Postal Code

99096

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Eschwege

ZIP/Postal Code

37269

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45131

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45138

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45257

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt am Main

ZIP/Postal Code

60313

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt am Main

ZIP/Postal Code

60594

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60313

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79098

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Friedrichshafen

ZIP/Postal Code

88048

Country

Germany

Facility Name

Novartis Investigative Site

City

Fulda

ZIP/Postal Code

36037

Country

Germany

Facility Name

Novartis Investigative Site

City

Fulda

ZIP/Postal Code

36043

Country

Germany

Facility Name

Novartis Investigative Site

City

Geldern

ZIP/Postal Code

47608

Country

Germany

Facility Name

Novartis Investigative Site

City

Gelnhausen

ZIP/Postal Code

63571

Country

Germany

Facility Name

Novartis Investigative Site

City

Gelsenkirchen

ZIP/Postal Code

45879

Country

Germany

Facility Name

Novartis Investigative Site

City

Gilching

ZIP/Postal Code

82205

Country

Germany

Facility Name

Novartis Investigative Site

City

Gladenbach

ZIP/Postal Code

35075

Country

Germany

Facility Name

Novartis Investigative Site

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

Novartis Investigative Site

City

Grevenbroich

ZIP/Postal Code

41515

Country

Germany

Facility Name

Novartis Investigative Site

City

Griesheim

ZIP/Postal Code

64347

Country

Germany

Facility Name

Novartis Investigative Site

City

Guetersloh

ZIP/Postal Code

33332

Country

Germany

Facility Name

Novartis Investigative Site

City

Gummersbach

ZIP/Postal Code

51643

Country

Germany

Facility Name

Novartis Investigative Site

City

Göttingen

ZIP/Postal Code

37073

Country

Germany

Facility Name

Novartis Investigative Site

City

Haar

ZIP/Postal Code

85540

Country

Germany

Facility Name

Novartis Investigative Site

City

Hagen

ZIP/Postal Code

58095

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle (Saale)

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle S

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22083

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22179

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22297

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22523

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30161

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30171

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidenheim

ZIP/Postal Code

89518

Country

Germany

Facility Name

Novartis Investigative Site

City

Herdecke

ZIP/Postal Code

58313

Country

Germany

Facility Name

Novartis Investigative Site

City

Herford

ZIP/Postal Code

32049

Country

Germany

Facility Name

Novartis Investigative Site

City

Herford

ZIP/Postal Code

32052

Country

Germany

Facility Name

Novartis Investigative Site

City

Hildesheim

ZIP/Postal Code

31134

Country

Germany

Facility Name

Novartis Investigative Site

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

Novartis Investigative Site

City

Hoppegarten

ZIP/Postal Code

15366

Country

Germany

Facility Name

Novartis Investigative Site

City

Ibbenbueren

ZIP/Postal Code

49477

Country

Germany

Facility Name

Novartis Investigative Site

City

Idar-Oberstein

ZIP/Postal Code

55743

Country

Germany

Facility Name

Novartis Investigative Site

City

Isselburg-Anholt

ZIP/Postal Code

46419

Country

Germany

Facility Name

Novartis Investigative Site

City

Itzehoe

ZIP/Postal Code

25524

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07743

Country

Germany

Facility Name

Novartis Investigative Site

City

Juelich

ZIP/Postal Code

52428

Country

Germany

Facility Name

Novartis Investigative Site

City

Kaiserslautern

ZIP/Postal Code

67655

Country

Germany

Facility Name

Novartis Investigative Site

City

Kaltenkirchen

ZIP/Postal Code

24568

Country

Germany

Facility Name

Novartis Investigative Site

City

Kandel

ZIP/Postal Code

76870

Country

Germany

Facility Name

Novartis Investigative Site

City

Karlstadt

ZIP/Postal Code

97753

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34121

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Novartis Investigative Site

City

Klingenmünster

ZIP/Postal Code

76889

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln-Longerich

ZIP/Postal Code

50737

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

51109

Country

Germany

Facility Name

Novartis Investigative Site

City

Koln

ZIP/Postal Code

50935

Country

Germany

Facility Name

Novartis Investigative Site

City

Korbach

ZIP/Postal Code

34497

Country

Germany

Facility Name

Novartis Investigative Site

City

Krefeld

ZIP/Postal Code

47800

Country

Germany

Facility Name

Novartis Investigative Site

City

Krefeld

ZIP/Postal Code

47805

Country

Germany

Facility Name

Novartis Investigative Site

City

Köln

ZIP/Postal Code

50674

Country

Germany

Facility Name

Novartis Investigative Site

City

Königsbrück

ZIP/Postal Code

01936

Country

Germany

Facility Name

Novartis Investigative Site

City

Landshut

ZIP/Postal Code

84028

Country

Germany

Facility Name

Novartis Investigative Site

City

Lappersdorf

ZIP/Postal Code

93138

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04157

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04275

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04299

Country

Germany

Facility Name

Novartis Investigative Site

City

Leverkusen

ZIP/Postal Code

51375

Country

Germany

Facility Name

Novartis Investigative Site

City

Lohr am Main

ZIP/Postal Code

79816

Country

Germany

Facility Name

Novartis Investigative Site

City

Lubeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigshafen

ZIP/Postal Code

67059

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

Facility Name

Novartis Investigative Site

City

Luenen

ZIP/Postal Code

44534

Country

Germany

Facility Name

Novartis Investigative Site

City

Luneburg

ZIP/Postal Code

21335

Country

Germany

Facility Name

Novartis Investigative Site

City

Lutherstadt Eisleben

ZIP/Postal Code

06295

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39104

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Novartis Investigative Site

City

Mannheim

ZIP/Postal Code

66163

Country

Germany

Facility Name

Novartis Investigative Site

City

Mannheim

ZIP/Postal Code

68159

Country

Germany

Facility Name

Novartis Investigative Site

City

Mannheim

ZIP/Postal Code

68161

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Novartis Investigative Site

City

Meisenheim

ZIP/Postal Code

55590

Country

Germany

Facility Name

Novartis Investigative Site

City

Minden

ZIP/Postal Code

32423

Country

Germany

Facility Name

Novartis Investigative Site

City

Minden

ZIP/Postal Code

32429

Country

Germany

Facility Name

Novartis Investigative Site

City

Mittweida

ZIP/Postal Code

09648

Country

Germany

Facility Name

Novartis Investigative Site

City

Mosbach

ZIP/Postal Code

74821

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80331

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Mönchengladbach

ZIP/Postal Code

41063

Country

Germany

Facility Name

Novartis Investigative Site

City

Mönchengladbach

ZIP/Postal Code

41239

Country

Germany

Facility Name

Novartis Investigative Site

City

Mülheim

ZIP/Postal Code

45481

Country

Germany

Facility Name

Novartis Investigative Site

City

München

ZIP/Postal Code

81829

Country

Germany

Facility Name

Novartis Investigative Site

City

Münster

ZIP/Postal Code

48147

Country

Germany

Facility Name

Novartis Investigative Site

City

Nagold

ZIP/Postal Code

72202

Country

Germany

Facility Name

Novartis Investigative Site

City

Naumburg

ZIP/Postal Code

06618

Country

Germany

Facility Name

Novartis Investigative Site

City

Neu-Ulm

ZIP/Postal Code

89231

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuburg an der Donau

ZIP/Postal Code

86633

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuruppin

ZIP/Postal Code

16816

Country

Germany

Facility Name

Novartis Investigative Site

City

Neusaess

ZIP/Postal Code

86356

Country

Germany

Facility Name

Novartis Investigative Site

City

Neustadt An Der Weinstraße

ZIP/Postal Code

67433

Country

Germany

Facility Name

Novartis Investigative Site

City

Nordhausen

ZIP/Postal Code

99734

Country

Germany

Facility Name

Novartis Investigative Site

City

Nürnberg

ZIP/Postal Code

90461

Country

Germany

Facility Name

Novartis Investigative Site

City

Offenbach

ZIP/Postal Code

63069

Country

Germany

Facility Name

Novartis Investigative Site

City

Oldenburg I. Holstein

ZIP/Postal Code

23758

Country

Germany

Facility Name

Novartis Investigative Site

City

Oldenburg

ZIP/Postal Code

26122

Country

Germany

Facility Name

Novartis Investigative Site

City

Osnabrueck

ZIP/Postal Code

49076

Country

Germany

Facility Name

Novartis Investigative Site

City

Osnabrück

ZIP/Postal Code

49074

Country

Germany

Facility Name

Novartis Investigative Site

City

Osnabrück

ZIP/Postal Code

49076

Country

Germany

Facility Name

Novartis Investigative Site

City

Osnabrück

ZIP/Postal Code

49078

Country

Germany

Facility Name

Novartis Investigative Site

City

Paderborn

ZIP/Postal Code

33098

Country

Germany

Facility Name

Novartis Investigative Site

City

Papenburg

ZIP/Postal Code

26871

Country

Germany

Facility Name

Novartis Investigative Site

City

Pforzheim

ZIP/Postal Code

75172

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14471

Country

Germany

Facility Name

Novartis Investigative Site

City

Prien

ZIP/Postal Code

83209

Country

Germany

Facility Name

Novartis Investigative Site

City

Quakenbrueck

ZIP/Postal Code

49610

Country

Germany

Facility Name

Novartis Investigative Site

City

Querfurt

ZIP/Postal Code

06268

Country

Germany

Facility Name

Novartis Investigative Site

City

Ravensburg

ZIP/Postal Code

88212

Country

Germany

Facility Name

Novartis Investigative Site

City

Recklinghausen

ZIP/Postal Code

45657

Country

Germany

Facility Name

Novartis Investigative Site

City

Regensburg

ZIP/Postal Code

93059

Country

Germany

Facility Name

Novartis Investigative Site

City

Remscheid

ZIP/Postal Code

42853

Country

Germany

Facility Name

Novartis Investigative Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Novartis Investigative Site

City

Rüdersdorf

ZIP/Postal Code

15562

Country

Germany

Facility Name

Novartis Investigative Site

City

Saarbruecken

ZIP/Postal Code

66113

Country

Germany

Facility Name

Novartis Investigative Site

City

Saint Ingbert

ZIP/Postal Code

66386

Country

Germany

Facility Name

Novartis Investigative Site

City

Sande

ZIP/Postal Code

26452

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwalmstadt-Treysa

ZIP/Postal Code

34613

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwerin

ZIP/Postal Code

19057

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57076

Country

Germany

Facility Name

Novartis Investigative Site

City

Singen

ZIP/Postal Code

78224

Country

Germany

Facility Name

Novartis Investigative Site

City

Sinsheim

ZIP/Postal Code

74889

Country

Germany

Facility Name

Novartis Investigative Site

City

Solingen

ZIP/Postal Code

42719

Country

Germany

Facility Name

Novartis Investigative Site

City

Stade

ZIP/Postal Code

21682

Country

Germany

Facility Name

Novartis Investigative Site

City

Stadtroda

ZIP/Postal Code

07646

Country

Germany

Facility Name

Novartis Investigative Site

City

Stralsund

ZIP/Postal Code

18439

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70174

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70176

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70178

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70182

Country

Germany

Facility Name

Novartis Investigative Site

City

Telgte

ZIP/Postal Code

48291

Country

Germany

Facility Name

Novartis Investigative Site

City

Teupitz

ZIP/Postal Code

15755

Country

Germany

Facility Name

Novartis Investigative Site

City

Troisdorf

ZIP/Postal Code

53844

Country

Germany

Facility Name

Novartis Investigative Site

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Unterhaching

ZIP/Postal Code

82008

Country

Germany

Facility Name

Novartis Investigative Site

City

Wasserburg

ZIP/Postal Code

83512

Country

Germany

Facility Name

Novartis Investigative Site

City

Wendlingen

ZIP/Postal Code

73240

Country

Germany

Facility Name

Novartis Investigative Site

City

Wermsdorf

ZIP/Postal Code

04779

Country

Germany

Facility Name

Novartis Investigative Site

City

Westerstede/Oldenburg

ZIP/Postal Code

26655

Country

Germany

Facility Name

Novartis Investigative Site

City

Westerstede

ZIP/Postal Code

26655

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

ZIP/Postal Code

65183

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

Novartis Investigative Site

City

Wolfratshausen

ZIP/Postal Code

82515

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuppertal

ZIP/Postal Code

42103

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuppertal

ZIP/Postal Code

42283

Country

Germany

Facility Name

Novartis Investigative Site

City

Würzburg

ZIP/Postal Code

97070

Country

Germany

Facility Name

Novartis Investigative Site

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Zwickau

ZIP/Postal Code

08060

Country

Germany

Facility Name

Novartis Investigative Site

City

Öhringen

ZIP/Postal Code

74613

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

28100182

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial