Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303
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|ClinicalTrials.gov Identifier: NCT04072835|
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : December 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Supraventricular Tachycardia||Drug: Etripamil NS||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||September 2, 2019|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2021|
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 Name: MSP-2017
- Safety of etripamil NS 70mg for the patient-administered treatment of acute episodes of PSVT outside of the clinical setting. [ Time Frame: 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.
- 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 [ Time Frame: 10 Months ]
- Improvement in patient quality of life measured by the Treatment Satisfaction Questionnaire for Medication and/or the Patient Reported Outcomes (PRO) System . [ Time Frame: 10 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072835
|Contact: Valeria Nogueirafirstname.lastname@example.org|