Clinical trial NCT03464019: Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxysmal Supraventricular Tachycardia (PSVT).
Official title: Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. NODE 301 and RAPID Studies
Conditions: Paroxysmal Supraventricular Tachycardia
Summary: This was a three-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by participants who experienced an episode of paroxysmal supraventricular tachycardia (PSVT) in an at-home setting.
NODE-301 Part 1 included participants that received the randomized study drug to treat an episode of PSVT until the 150th positively adjudicated PSVT episode. Part 2 (also referred as the RAPID study) included participants that did not receive the randomized study drug in Part 1 and newly enrolled participants until the 180th positively adjudicated PSVT episode in Part 2. The study continued for approximately 6 months after the 180th positively adjudicated PSVT episode in Part 2 and this extension is referred to as Part 3 (also referred to as RAPID Extension).
Interventions:
description: Etripamil administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
name: Etripamil
other_name: MSP-2017
type: Drug
description: Placebo administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
name: Placebo
type: Drug
description: During the Test Dose, etripamil administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
name: Etripamil Test Dose
other_name: MSP-2017 Test Dose
type: Drug
Study arms:
design_group_description: Self-administration of a single dose etripamil 70 mg for a perceived episode of PSVT.
design_group_title: Part 1: Etripamil 70 mg Single Dose
design_group_type: Experimental
design_group_description: Self-administration of a single dose of placebo for a perceived episode of PSVT.
design_group_title: Part 1: Placebo Single Dose
design_group_type: Placebo Comparator
design_group_description: Single test dose of etripamil 70 mg in sinus rhythm
design_group_title: Part 1: Test dose only (etripamil 70 mg)
design_group_type: Other
design_group_description: Self-administration of 70 mg etripamil for a perceived episode of PSVT followed 10 minutes later by an optional second dose of 70 mg etripamil, if symptoms persisted. Participants could be enrolled in the open-label period to treat an additional PSVT episode with etripamil.
design_group_title: Part 2 & Part 3: Etripamil 70 mg with Optional Second Dose
design_group_type: Experimental
design_group_description: Self-administration of placebo for a perceived episode of PSVT followed 10 minutes later by an optional second dose of placebo, if symptoms persisted. Participants could be enrolled in the open-label period to treat an additional PSVT episode with etripamil.
design_group_title: Part 2 & Part 3: Placebo with Optional Second Dose
design_group_type: Placebo Comparator
design_group_description: Repeat Test Dose of etripamil 70 mg (2X 70mg) 10 minutes apart in sinus rhythm
design_group_title: Part 2 & Part 3: Test dose only (etripamil 70 mg + 70 mg)
design_group_type: Other
Sponsor: Milestone Pharmaceuticals, Inc.
Collaborators: IQVIA Biotech LLC
Medpace, Inc.
Drug name mappings:
name: 艾曲帕米
lang: CN
name: Etripamil
lang: EN