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

Sponsor

Milestone Pharmaceuticals Inc. (Other)

Overall Status

Recruiting

CT.gov ID

NCT04072835

Collaborator

IQVIA Biotech (Industry)

3,000

Enrollment

124

Locations

Arm

Anticipated Duration (Months)

24.2

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

NODE-303 is a multi-center, open label (OL) study to evaluate the safety of etripamil NS in patients with Paroxysmal Supraventricular Tachycardia (PSVT). Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT symptoms begin. Patients will self-administer etripamil NS if vagal maneuver is ineffective. After an episode of PSVT where drug is administered, the patient will return to the investigative site for a study visit and will be given the option to continue in NODE-303 and manage subsequent episodes of PSVT with etripamil NS.

Condition or Disease	Intervention/Treatment	Phase
Paroxysmal Supraventricular Tachycardia	Drug: Etripamil NS	Phase 3

Detailed Description

NODE-303 is a multi-center, open label (OL) study to evaluate the safety of etripamil NS in patients with PSVT. Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT symptoms begin. Patients will self-administer etripamil NS if vagal maneuver is ineffective. After an episode of PSVT where drug is administered, the patient will return to the investigative site for a study visit and will be given the option to continue in NODE-303 and manage subsequent episodes of PSVT with etripamil NS.

The study will include:

A Screening Visit during which the Investigator will verify that the patient meets the eligibility criteria of the NODE-303 study, will obtain the signed informed consent, take blood and urine for laboratory evaluations, and conduct other screening procedures. The informed consent for NODE-303 will be applicable for the initial and all subsequent PSVT episodes. A Baseline Visit during which the site will confirm eligibility, concomitant medications, train the patient on study procedures, and give the patient study drug, patient reported outcome (PRO) materials, and the CMS materials. A Treatment Period during which the patient will complete the monthly PRO survey, self-identify symptoms of PSVT, use the CMS, perform a vagal maneuver (VM), and self-administer etripamil NS if the symptoms do not resolve during or after the VM. Patients may be contacted during this period for reminders and training on what to do during a PSVT episode. Patients will also complete a per episode survey after any PSVT episode they experience. During the Treatment Period, Follow-up Visits will occur at the study site up to 14 days after each episode of PSVT which is treated with etripamil NS, and during which the Investigator will evaluate the results of the last usage of etripamil NS and decide whether the patient can continue in the study and receive a new study drug kit. A Final Study Visit that will occur when a patient discontinues or withdraws from the study, or when the overall study is completed, or the patient has completed the maximum number of doses. NODE-303 will continue until enough documented self-administrations of etripamil NS are included in the safety database to meet regulatory requirements for the etripamil NS development program. The common study end date (CSED) for the entire study will depend on the rate of accrual of the primary endpoint, unique patients with an episode. When the criteria for concluding the study have been met, the Sponsor will announce the common study end date (CSED) for the entire study and sites will be informed in advance to schedule all final patient visits prior to the CSED.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The NODE-303 Study: Multi-Centre, Multi-National,Open Label, Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia.

Actual Study Start Date :

Sep 2, 2019

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Etripamil NS 70mg Patients will self-administer etripamil NS.	Drug: Etripamil NS Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT symptoms begin. Patients will self-administer etripamil NS if vagal maneuver is ineffective. After an episode of PSVT where drug is administered, the patient will return to the investigative site for a study visit and will be given the option to continue in NODE-303 and manage subsequent episodes of PSVT with etripamil NS. Other Names: MSP-2017

Arm

Intervention/Treatment

Experimental: Etripamil NS 70mg

Patients will self-administer etripamil NS.

Drug: Etripamil NS

Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT symptoms begin. Patients will self-administer etripamil NS if vagal maneuver is ineffective. After an episode of PSVT where drug is administered, the patient will return to the investigative site for a study visit and will be given the option to continue in NODE-303 and manage subsequent episodes of PSVT with etripamil NS.

Other Names:

MSP-2017

Outcome Measures

Primary Outcome Measures

Safety of etripamil NS 70mg for the patient-administered treatment of acute episodes of PSVT outside of the clinical setting. [10 months]
Measured by: Number of participants presenting Adverse Events and/or Number of participants with abnormal findings from the CMS recordings and physical examinations.

Secondary Outcome Measures

Efficacy of etripamil NS 70mg for the patient-administered treatment of acute episodes of PSVT outside of the clinical setting measured by median time to conversion post etripamil NS administration [10 Months]
Improvement in patient quality of life measured by the Treatment Satisfaction Questionnaire for Medication and/or the Patient Reported Outcomes (PRO) System . [10 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A patient will be eligible for study participation if they meet all of the following criteria:

Has been diagnosed with PSVT by a medical professional, and reports having at least one previous episode of PSVT. For clarity, PSVT refers to episodic Supraventricular Tachycardia (SVT) that includes the atrioventricular (AV) node as a critical part of reentrant circuit.
Is at least 18 years of age;
Signed NODE-303 written informed consent
Women of child-bearing potential must be willing to use at least 1 form of contraception during the trial, and must be willing to discontinue from the study should they become or plan to become pregnant
Willing and able to comply with study procedures

Exclusion Criteria:

A patient will be excluded from the study if they meet any of the following criteria:

Patients with only a history of atrial arrhythmia that does not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g. atrial fibrillation, atrial flutter, intra-atrial tachycardia) are not eligible. Patients with a history of these tachycardias who are also diagnosed with PSVT are eligible.
History of allergic reaction to verapamil
Current therapy with digoxin, or any Class I or III antiarrhythmic drug. Patients may be eligible if these drugs are stopped at least five half-lives before the administration of etripamil NS. The only exception is amiodarone which must be stopped 30 days before enrollment.
History of ventricular pre-excitation, e.g., delta waves, Wolff- Parkinson-White syndrome
History of a second- or third-degree AV block
Symptoms of congestive heart failure New York Heart Association Class II to IV
Significant physical or psychiatric condition including alcoholism or drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of the patient, or impede the patient's capacity to follow the study procedures
History of syncope due to an arrhythmic etiology at any time, or history in last 5 years of unexplained syncope
Is pregnant or breastfeeding
Previously enrolled in a clinical trial for etripamil and received study drug
History of Acute Coronary Syndrome (ACS) or stroke within 6 months of screening
Evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the Screening Visit as follows:
<60mL/min/1.73m2 for patients <60 years of age;
<40mL/min/1.73m2 for patients ≥60 and <70 years of age c) <35mL/min/1.73m2 for patients ≥70 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1077	Gilbert	Arizona	United States	85297
2	1121	Fremont	California	United States	94538
3	1035	Stanford	California	United States	94305
4	1023	Vista	California	United States	92083
5	1083	West Hills	California	United States	91307
6	101	Littleton	Colorado	United States	80120
7	1010	Bridgeport	Connecticut	United States	06610
8	1066	Trumbull	Connecticut	United States	06611
9	1042	Bradenton	Florida	United States	34208
10	1106	Daytona Beach	Florida	United States	32117
11	1107	Edgewater	Florida	United States	32132
12	1032	Hialeah	Florida	United States	33016
13	1026	Miami	Florida	United States	33157
14	1055	Miami	Florida	United States	33176
15	1064	Naples	Florida	United States	34102
16	1071	North Miami Beach	Florida	United States	33162
17	1009	Orlando	Florida	United States	32803
18	1060	Saint Augustine	Florida	United States	32086
19	1022	Cumming	Georgia	United States	30041
20	137	Macon	Georgia	United States	31201
21	1115	Coeur d'Alene	Idaho	United States	83814
22	1045	Peoria	Illinois	United States	61602
23	149	Fort Wayne	Indiana	United States	90720
24	1025	West Des Moines	Iowa	United States	50266
25	1008	Monroe	Louisiana	United States	71201
26	1007	Salisbury	Maryland	United States	21804
27	1078	Boston	Massachusetts	United States	02215
28	166	Lansing	Michigan	United States	48912
29	119	Rochester	Minnesota	United States	55902
30	1093	Saint Paul	Minnesota	United States	55101
31	1099	Kansas City	Missouri	United States	64111
32	1134	Elmer	New Jersey	United States	08318
33	1133	Haddon Heights	New Jersey	United States	08035
34	114	New York	New York	United States	10021
35	1021	Southampton	New York	United States	11968
36	129	Charlotte	North Carolina	United States	28204
37	1065	Charlotte	North Carolina	United States	28277
38	1079	Mount Airy	North Carolina	United States	27030
39	1018	Statesville	North Carolina	United States	28625
40	1024	Canton	Ohio	United States	44710
41	123	Cincinnati	Ohio	United States	45242
42	142	Columbus	Ohio	United States	31904
43	1086	Oklahoma City	Oklahoma	United States	73135
44	1123	Corvallis	Oregon	United States	97330
45	1031	Hershey	Pennsylvania	United States	17033-0850
46	1082	Wyomissing	Pennsylvania	United States	19610
47	105	Yardley	Pennsylvania	United States	19067
48	1097	York	Pennsylvania	United States	17403
49	122	Rapid City	South Dakota	United States	57701
50	1062	Jackson	Tennessee	United States	38301
51	1012	Memphis	Tennessee	United States	38104
52	1047	Austin	Texas	United States	78705
53	1092	Austin	Texas	United States	78705
54	1016	Fort Worth	Texas	United States	76104
55	1017	Houston	Texas	United States	77017
56	1048	Plano	Texas	United States	75093
57	1014	San Antonio	Texas	United States	78220
58	1004	Riverton	Utah	United States	84096
59	117	Lynchburg	Virginia	United States	24501
60	1076	Richmond	Virginia	United States	23235
61	0116	Richmond	Virginia	United States	23298
62	5106	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	1428
63	5117	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	1430
64	5112	Mar Del Plata	Buenos Aires	Argentina	B7600FYK
65	5105	Mar Del Plata	Buenos Aires	Argentina	B7600FZN
66	5115	Quilmes	Buenos Aires	Argentina	B1878DVB
67	5122	Ramos Mejía	Buenos Aires	Argentina	B1704ETD
68	5110	San Nicolas	Buenos Aires	Argentina	2900
69	5125	Ciudad Autonoma de Buenos Aires		Argentina	C1013AAB
70	5129	Ciudad Autónoma de Buenos Aires		Argentina	1425
71	5134	Corrientes		Argentina	3400
72	5116	Córdoba		Argentina	5000
73	5123	Córdoba		Argentina	5000
74	5118	Córdoba		Argentina	X5003DCE
75	5102	La Plata		Argentina	1900
76	5132	Rosario		Argentina	2000
77	5109	Salta		Argentina	4400
78	5130	San Nicolas		Argentina	B2900DPA
79	5124	Temperley		Argentina	1834
80	5221	Belo Horizonte	Reg1	Brazil	30110-934
81	5217	Brasília	Reg1	Brazil	70390903
82	5215	Campinas	Reg1	Brazil	13060-080
83	5222	Canoas	Reg1	Brazil	92425
84	5207	Curitiba	Reg1	Brazil	80320-320
85	5227	Juiz de Fora	Reg1	Brazil	36033-318
86	5209	Recife	Reg1	Brazil	50100060
87	5214	Salvador	Reg1	Brazil	40320-010
88	5219	Santo André	Reg1	Brazil	09030-010
89	5212	Sao Jose do Rio Preto	Reg1	Brazil	15015-210
90	5220	São Paulo	Reg1	Brazil	01506-000
91	5225	São Paulo	Reg1	Brazil	08270-070
92	5205	Uberlândia	Reg1	Brazil	38411-186
93	5228	Belo Horizonte		Brazil	30150-320
94	5202	Campinas		Brazil	13010-001
95	5201	Goiânia		Brazil	74210-050
96	5229	Jaú		Brazil	17201130
97	5235	Rio De Janeiro		Brazil	20241-180
98	5232	São Paulo		Brazil	05403-000
99	5204	Tatuí		Brazil	18270-170
100	5231	Votuporanga		Brazil	15500-003
101	2003	Saint-Jerome	Alberta	Canada	J7Z 5T3
102	2017	Kelowna	British Columbia	Canada	V1Y 1T2
103	2010	North Vancouver	British Columbia	Canada	V7M 2H4
104	2019	Saskatoon	British Columbia	Canada	S7N 0W8
105	2018	Surrey	British Columbia	Canada	V3V 0C6
106	212	Vancouver	British Columbia	Canada	V5Z 1M9
107	213	Victoria	British Columbia	Canada	V8T 1Z4
108	215	Cambridge	Ontario	Canada	N1R 6V6
109	202	Hamilton	Ontario	Canada	L8L 0A6
110	2006	Oshawa	Ontario	Canada	L1J 2K1
111	2001	Ottawa	Ontario	Canada	K1Y 4W7
112	2011	Greenfield Park	Quebec	Canada	J4V 2G8
113	2020	Levis	Quebec	Canada	G6V 4Z5
114	203	Montreal	Quebec	Canada
115	205	Montréal	Quebec	Canada	H2X 0A9
116	2014	Québec	Quebec	Canada	G1R 2J6
117	201	Sherbrooke	Quebec	Canada	J1H 5N4
118	2002	St Jean sur Richelieu	Quebec	Canada	J3A 1J2
119	5409	Armenia		Colombia	630004
120	5404	Barranquilla		Colombia	80020
121	5408	Bucaramanga		Colombia	680002
122	5401	Medellín		Colombia	050034
123	5407	Punta de Cartagena		Colombia	130013
124	5403	San Gil		Colombia	684031

Sponsors and Collaborators

Milestone Pharmaceuticals Inc.
IQVIA Biotech

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Milestone Pharmaceuticals Inc.

ClinicalTrials.gov Identifier:

NCT04072835

Other Study ID Numbers:

NODE-303

First Posted:

Aug 28, 2019

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Milestone Pharmaceuticals Inc.

PSVT

Additional relevant MeSH terms:

Tachycardia

Tachycardia, Supraventricular

Tachycardia, Ventricular

Etripamil

Study Results

No Results Posted as of Jul 27, 2022