Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303

PHASE3CompletedINTERVENTIONAL
Enrollment

1,116

Participants

Timeline

Start Date

September 23, 2019

Primary Completion Date

January 26, 2023

Study Completion Date

January 26, 2023

Conditions
Paroxysmal Supraventricular Tachycardia
Interventions
DRUG

Etripamil NS

Participants were provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS was self-applied by the participant, when PSVT symptoms begin. Participants self-administered etripamil NS if vagal maneuver was ineffective. After implementation of protocol amendment 2.1, participants had the option to administer a second dose of etripamil 70 mg 10 minutes after the first dose, if symptoms persisted. After an episode of PSVT where drug was administered, the participant returned to the investigative site for a study visit and was given the option to continue in NODE-303 and manage up to three subsequent episodes of PSVT with etripamil NS for a maximum of four episodes.

Trial Locations (124)

1425

5129, Buenos Aires

1428

5106, Ciudad Autonoma de Buenos Aires

1430

5117, Ciudad Autonoma de Buenos Aires

1834

5124, Temperley

1900

5102, La Plata

2000

5132, Rosario

2900

5110, San Nicolás de los Arroyos

3400

5134, Corrientes

4400

5109, Salta

5000

5116, Córdoba

5123, Córdoba

10021

114, New York

11968

1021, Southampton

17403

1097, York

19067

105, Yardley

19610

1082, Wyomissing

21804

1007, Salisbury

23235

1076, Richmond

23298

0116, Richmond

24501

117, Lynchburg

27030

1079, Mount Airy

28204

129, Charlotte

28277

1065, Charlotte

28625

1018, Statesville

30041

1022, Cumming

31201

137, Macon

31904

142, Columbus

32086

1060, Saint Augustine

32117

1106, Daytona Beach

32132

1107, Edgewater

32803

1009, Orlando

33016

1032, Hialeah

33157

1026, Miami

33162

1071, North Miami Beach

33176

1055, Miami

34102

1064, Naples

34208

1042, Bradenton

38104

1012, Memphis

38301

1062, Jackson

44710

1024, Canton

45242

123, Cincinnati

48912

166, Lansing

50266

1025, West Des Moines

55101

1093, Saint Paul

55902

119, Rochester

57701

122, Rapid City

61602

1045, Peoria

64111

1099, Kansas City

71201

1008, Monroe

73135

1086, Oklahoma City

75093

1048, Plano

76104

1016, Fort Worth

77017

1017, Houston

78220

1014, San Antonio

78705

1047, Austin

1092, Austin

80020

5404, Barranquilla

80120

101, Littleton

83814

1115, Coeur d'Alene

84096

1004, Riverton

85297

1077, Gilbert

90720

149, Fort Wayne

91307

1083, West Hills

92083

1023, Vista

92425

5222, Canoas

94305

1035, Stanford

94538

1121, Fremont

97330

1123, Corvallis

130013

5407, Punta de Cartagena

630004

5409, Armenia

680002

5408, Bucaramanga

684031

5403, San Gil

17201130

5229, Jaú

50100060

5209, Recife

70390903

5217, Brasília

06610

1010, Bridgeport

06611

1066, Trumbull

02215

1078, Boston

08318

1134, Elmer

08035

1133, Haddon Heights

17033-0850

1031, Hershey

B7600FYK

5112, Mar del Plata

B7600FZN

5105, Mar del Plata

B1878DVB

5115, Quilmes

B1704ETD

5122, Ramos Mejía

C1013AAB

5125, Buenos Aires

X5003DCE

5118, Córdoba

B2900DPA

5130, San Nicolás

30110-934

5221, Belo Horizonte

13060-080

5215, Campinas

80320-320

5207, Curitiba

36033-318

5227, Juiz de Fora

40320-010

5214, Salvador

09030-010

5219, Santo André

15015-210

5212, São José do Rio Preto

01506-000

5220, São Paulo

08270-070

5225, São Paulo

38411-186

5205, Uberlândia

30150-320

5228, Belo Horizonte

13010-001

5202, Campinas

74210-050

5201, Goiânia

20241-180

5235, Rio de Janeiro

05403-000

5232, São Paulo

18270-170

5204, Tatuí

15500-003

5231, Votuporanga

V1Y 1T2

2017, Kelowna

V7M 2H4

2010, North Vancouver

S7N 0W8

2019, Saskatoon

V3V 0C6

2018, Surrey

V5Z 1M9

212, Vancouver

V8T 1Z4

213, Victoria

N1R 6V6

215, Cambridge

L8L 0A6

202, Hamilton

L1J 2K1

2006, Oshawa

K1Y 4W7

2001, Ottawa

J4V 2G8

2011, Greenfield Park

G6V 4Z5

2020, Lévis

H2X 0A9

205, Montreal

Unknown

203, Montreal

G1R 2J6

2014, Québec

J3A 1J2

2002, Saint-Jean-sur-Richelieu

J7Z 5T3

2003, Saint-Jérôme

J1H 5N4

201, Sherbrooke

050034

5401, Medellín

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

IQVIA Biotech

INDUSTRY

lead

Milestone Pharmaceuticals Inc.

OTHER