Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302
Recruiting in Palo Alto (17 mi)
+33 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Milestone Pharmaceuticals Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The primary objective of this study is to evaluate the safety of etripamil nasal spray (NS) 70 mg when self-administered by patients with an episode of Paroxysmal Supraventricular Tachycardia in an outpatient setting (i.e., without medical supervision).
Research Team
Eligibility Criteria
Inclusion Criteria
Male or female patients at least 18 years of age;
Signed the NODE-302 written informed consent;
Received the study drug to treat symptoms the patient believed were consistent with an episode of PSVT during the NODE-301 study, irrespective of the study drug efficacy; OR Did not experience an episode of PSVT or did not use the study drug at the time of the NODE-301 study completion;
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Treatment Details
Interventions
- Aptar Pharma Nasal Spray Bidose System (Device)
- Etripamil NS 70 mg (Calcium Channel Blocker)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Etripamil NS 70 mgExperimental Treatment2 Interventions
The dose of etripamil to be evaluated in NODE-302 is 70 mg.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milestone Pharmaceuticals Inc.
Lead Sponsor
Trials
11
Recruited
4,500+
Medpace, Inc.
Industry Sponsor
Trials
98
Recruited
30,400+
Dr. August J. Troendle
Medpace, Inc.
Chief Executive Officer since 1992
MD from the University of Maryland, School of Medicine; MBA from Boston University
Dr. Reinilde Heyrman
Medpace, Inc.
Chief Medical Officer since 2017
MD