Efficacy and Safety of Intranasal MSP-2017 (Etripamil) for the Conversion of PSVT to Sinus Rhythm



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:7/29/2016
Start Date:January 2015
End Date:September 2016
Contact:Philippe Douville
Phone:514-336-0444

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

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.

This is a multi-center, randomized, double-blind, placebo-controlled, dose-ranging study to
evaluate the effects of 4 different doses of MSP-2017 (Etripamil) in subjects with
paroxysmal supraventricular tachycardia. It includes an up to 21-day Screening Period, a
1-day Treatment Visit, and either a Follow-up Visit or Early Termination Visit occurring 12
hours to 5 days after the Treatment Visit. Subjects will be randomized to yield at least 100
evaluable subjects distributed into 5 groups of at least 20 subjects each.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Has a history of serious allergic reaction to verapamil (especially when administered
intravenously) including rash, itching or swelling (especially of the face, tongue,
or throat), severe dizziness, or trouble breathing

- Is currently participating in another drug or device study, or has received an
investigational drug or device within 30 days of Screening

- Has evidence of clinically significant cardiovascular, endocrine, gastrointestinal,
hematologic, hepatic, immunologic, neurologic, oncologic, pulmonary, psychiatric, or
renal disease or any other condition which, in the opinion of the Investigator, would
jeopardize the safety of the subject or impact the validity of study results

- Is a female who is breast feeding, pregnant, or planning to become pregnant during
the study period

- Has evidence of any clinically significant acute or chronic condition of the nasal
cavity (e.g., rhinitis or deviated septum) which could interfere with IN
administration of the study drug in either or both nasal cavities

- Has any of the following at screening or at the Treatment Visit: Systolic blood
pressure <100 mmHg, Diastolic blood pressure <50 mmHg

- Has evidence of hepatic impairment, defined as: Alanine aminotransferase or aspartate
aminotransferase levels that are greater than or equal to 3× upper limit of normal
(ULN) or Bilirubin levels that are greater than or equal to 2× ULN, unless due to
Gilbert's syndrome

- Has evidence of renal impairment, defined as an estimated glomerular filtration rate
<30 mL/min (Modification of Diet in Renal Disease method)

- Has taken digoxin, verapamil, diltiazem, or any Class I, II (e.g., beta blockers), or
III antiarrhythmic drug less than the equivalent of 5 half-lives of this drug prior
to the Treatment Visit

- Has taken amiodarone within 30 days of the Treatment Visit

- Has taken drugs of abuse which, in the opinion of the Investigator, would impact the
validity of study results

- Has had myocardial infarction, percutaneous coronary intervention, cerebrovascular
accident, transient ischemic attack, unstable angina, or acute decompensation of
heart failure within 6 months of Screening

- Has a history or evidence of second- or third-degree atrioventricular block

- Has an implanted device (e.g., pacemaker, or implantable cardioverter defibrillator)
that precludes study participation in the opinion of the Investigator and Study
Medical Monitor

- Has a history or evidence of preexcitation syndrome (e.g., Wolff-Parkinson- White
syndrome, short PR, etc.)

- Has evidence of a QT interval (Bazett's correction) (QTcB) >455 milliseconds at
Screening or at the Treatment Visit

- Has a history or evidence of familial long QT syndrome, torsades de pointes,
ventricular fibrillation, sustained ventricular tachycardia, Brugada syndrome, or
sudden cardiac death

- Has evidence of recurrent or chronic atrial tachycardia, atrial flutter, or atrial
fibrillation; that could interfere with the current investigation; or

- Has a history or evidence of congestive heart failure (except New York Heart
Association Class I) or pulmonary edema

In addition, randomized subjects who meet any of the following criteria at the Treatment
Visit (Day 1) prior to study drug administration, will be excluded from participation in
the study:

- PSVT cannot be induced or the mechanism of PSVT is neither AVRT nor A VNRT

- It is not possible to sustain an episode of PSVT for 5 minutes

- The subject requires a continuous sedative (e.g., propofol), continuous analgesic, or
inhaled anesthetic at any point until time 30. Minimally necessary dose(s) of
benzodiazepine(s) (e.g., midazolam) and/or narcotic(s) (e.g., fentanyl) (given via
single or multiple administration[s]) may be used at the Investigator's discretion.
The identity(-ies) and actual administered dose(s) of any benzodiazepine(s) and/or
narcotic(s) should be recorded in the study documentation. Local anesthetic(s) may be
used at the Investigator's discretion; any use should be recorded in the study
documentation

- The subject has undergone prior ablation, and the subject's AV node function is
abnormal in the opinion of the Investigator
We found this trial at
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Rapid City, South Dakota 57701
Principal Investigator: Jose Teixeira
Phone: 605-755-4326
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Atlanta, Georgia 30309
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
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Phone: 404-712-5592
Emory University Hospital As the largest health care system in Georgia and the only health...
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Austin, Texas 78758
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Baltimore, Maryland 21237
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Canton, Ohio 44708
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Charlottesville, Virginia 22908
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Cincinnati, Ohio 45267
Principal Investigator: Alexandru Costea
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Houston, Texas 77030
Principal Investigator: Wilson Lam
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Amish Dave
Phone: 713-441-6465
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Jacksonville, Florida 32216
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Jacksonville, Florida 32216
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Dhanunjaya Lakkireddy
Phone: 913-588-9627
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Littleton, Colorado 80120
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Lynchburg, Virginia 24501
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
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Phoenix, Arizona 85054
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Phoenix, Arizona 53226
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Rochester, Minnesota 55905
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Sacramento, California 95819
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