Multi-Center, Placebo-Controlled, Dose-Ranging Phase 2 Electrophysiological Study of Intranasal Administration of MSP-2017 for the Conversion of Induced Paroxysmal Supraventricular Tachycardia (PSVT) to Sinus Rhythm

Status: Completed
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The primary objective of this study is to demonstrate the superiority of at least 1 dose of intranasal (IN) MSP-2017 (Etripamil) over placebo in terminating PSVT induced in an electrophysiology (EP) laboratory.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Male or female, aged 18 years and older at Screening

• Has a history of PSVT

• Is scheduled for an electrophysiology study and catheter ablation

• Has provided written informed consent

• Agrees to use a medically accepted form of contraception or abstinence to prevent pregnancy. Males must agree to use an acceptable form of contraception or abstinence from the time of study drug administration through the Follow-up Visit. Females must agree to use an acceptable form of contraception or abstinence from Screening until 30 days following study drug administration. Post-menopausal female subjects must be amenorrheic for ≥ 12 months prior to Screening or ≥ 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) prior to Screening, if they do not wish to use an acceptable form of contraception or abstinence. Acceptable forms of contraception include: A condom and an intrauterine device; A condom and hormonal contraception; A condom and a diaphragm; Sterilization of the subject or the subject's partner(s) (sterilization procedure must have been performed 3 or more months prior); Hysterectomy of the subject or the subject's partner(s)

• If a female of childbearing potential: Has a negative serum pregnancy test result at Screening (Screening must occur ≥7 days prior to randomization [ie, on or before Day -7]) and at the Treatment Visit (pre-PSVT induction); Has had a menstrual period within 28 days of the Treatment Visit.

Locations
United States
Arizona
Arizona Heart Rhythm Center
Phoenix
Mayo Clinic Arizona
Phoenix
California
Mercy General Hospital
Sacramento
Colorado
South Denver Cardiology Associates
Littleton
Washington, D.c.
Medstar Washington Hospital Center
Washington
Florida
Mayo Clinic Jacksonville
Jacksonville
Memorial Hospital Jacksonville
Jacksonville
Northside Hospital
Saint Petersburg
University of South Florida Health South Tampa Center
Tampa
Georgia
Emory University Hospital
Atlanta
Piedmont Atlanta Hospital
Atlanta
Iowa
Iowa Heart Center
West Des Moines
Kansas
University of Kansas Medical Center
Kansas City
Maryland
MedStar Health Research Institute
Baltimore
Minnesota
Mayo Clinic
Rochester
Ohio
Aultman Hospital Cardiology Clinical Trials
Canton
University of Cincinnati Medical Center Division of Cardiovascular Diseases
Cincinnati
ProMedica Toledo Hospital
Toledo
Great Lakes Medical Research, LLC
Willoughby
South Dakota
Black Hills Cardiovascular Research
Rapid City
Texas
Texas Cardiac Arrhythmia Research Foundation
Austin
Baylor St. Luke's Hospital
Houston
Houston Methodist Hospital
Houston
Virginia
University of Virginia Medical Center
Charlottesville
Centra Stroobants Cardiovascular Center
Lynchburg
Sentara Norfolk General Hospital
Norfolk
Other Locations
Canada
CHUM Hotel Dieu
Montreal
The Montreal Heart Institute
Montreal
St. Michael's Hospital
Toronto
Sunnybrook Health Sciences Center
Toronto
Time Frame
Start Date: March 27, 2015
Completion Date: December 2016
Participants
Target number of participants: 199
Treatments
Experimental: Etripamil
1 dose of Etripamil via 4 intranasal applications at time 0 (140 mg, 105 mg, 70 mg, or 35 mg)
Placebo Comparator: Placebo
1 dose of placebo via 4 intranasal applications at time 0
Authors
Sponsors
Leads: Milestone Pharmaceuticals Inc.
Collaborators: Medpace, Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials