Etripamil Nasal Spray for Rapid Heartbeat
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Milestone Pharmaceuticals Inc.
Must not be taking: Beta blockers, Calcium blockers
Disqualifiers: Atrial arrhythmia, Long QT, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?NODE-202 is a Phase 2, multicenter, multinational, single dose, open-label, 2-part, sequential design study in pediatric patients with an established diagnosis of paroxysmal supraventricular tachycardia (PSVT) presenting with a symptomatic episode of PSVT.
In Part 1, at least 30 patients aged 12 to \<18 years will be enrolled and treated with etripamil nasal spray (NS). Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of 70 mg etripamil NS (Part 1A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the Pharmacokinetic (PK) analysis and will undergo efficacy and safety/tolerability assessments (Part 1B).
In Part 2, at least 30 patients aged 6 to \<12 years will be enrolled and treated with etripamil NS at a dose selected based on appropriate body size-based modeling, as well as efficacy, safety/tolerability, and PK data collected in Part 1. Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of etripamil NS (Part 2A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the PK analysis and will undergo efficacy and safety/tolerability assessments (Part 2B).
The study will include the following visits: A Screening Visit, A Treatment Visit, , and A Follow-Up/End of Study Visit.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as IV beta-blockers, calcium channel blockers, and amiodarone, before participating. If you are on any investigational drugs or specific antiarrhythmic agents, you may also need to discontinue them. Please discuss with the study team to understand which medications you need to stop.
How is Etripamil Nasal Spray different from other drugs for rapid heartbeat?
Etripamil Nasal Spray is unique because it is administered through the nose, allowing for rapid absorption and quick action, which is beneficial for treating rapid heartbeat. This nasal route avoids the first-pass metabolism that occurs with oral medications, potentially leading to higher bioavailability and faster relief.
12345Eligibility Criteria
The NODE-202 study is for kids and teens with a rapid heartbeat condition called PSVT. Participants aged 12 to less than 18 can join Part 1, while those aged 6 to less than 12 can join Part 2. They should have a BMI within the normal range for their age and sex, documented history of PSVT, and if post-ablation, evidence of PSVT recurrence. A negative pregnancy test and agreement to use contraception are required.Inclusion Criteria
You need to use birth control unless you are not having any sexual activity.
My BMI is within the healthy range for my age and sex.
I have a history of rapid heartbeats confirmed by a heart monitor.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Treatment
Participants receive etripamil nasal spray during a symptomatic episode of PSVT, with efficacy, safety, tolerability, and PK assessments
Single dose
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including recording of adverse events and ECG
1 to 5 days
1 visit (in-person)
Open-label extension (optional)
Participants may opt into continuation of treatment long-term if deemed beneficial
Long-term
Participant Groups
This trial tests Etripamil Nasal Spray (NS) in two age groups: first in older children (Part 1), then younger ones (Part 2). It's an open-label study where everyone gets the drug. The dose is based on body size and previous results from older participants. Researchers will check how well it works, its safety, tolerability, and how the body processes it.
1Treatment groups
Experimental Treatment
Group I: Etripamil NS 70mgExperimental Treatment1 Intervention
Patients will be administered by study site personnel
Etripamil NS is already approved in United States for the following indications:
🇺🇸 Approved in United States as CARDAMYST for:
- Paroxysmal supraventricular tachycardia (PSVT)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Le Bonheur Children's HospitalMemphis, TN
Advocate Children's HospitalOak Lawn, IL
Oregon Health and Science UniversityPortland, OR
Cincinnati Children's Hospital Medical CenterCincinnati, OH
More Trial Locations
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Who Is Running the Clinical Trial?
Milestone Pharmaceuticals Inc.Lead Sponsor
References
Onset of action of aqueous beclomethasone dipropionate nasal spray in seasonal allergic rhinitis. [2019]Beclomethasone dipropionate nasal spray is widely used in the treatment of seasonal allergic rhinitis; however, the time of onset of action has not been determined. This study assessed the onset of action, level of relief, and efficacy of beclomethasone nasal spray in patients with seasonal allergic rhinitis. In a double-blind, randomized, placebo-controlled, parallel-group, multicenter, 7-day study, symptomatic patients were administered two inhalations of beclomethasone dipropionate (n = 80) or placebo (n = 81) into each nostril twice daily. Patients assessed the onset of action and level of relief at 6, 24, and 48 hours and at days 3 and 7. Investigators evaluated symptoms at days 0, 3, and 7 and response to therapy at days 3 and 7. The difference in the cumulative number of patients reporting relief of symptoms was statistically significant in favor of beclomethasone dipropionate by hour 24 (P = 0.05). Patients in the beclomethasone dipropionate group experienced a greater level of relief than patients receiving placebo at hour 24, and improvement increased over the 7-day study compared with a decrease in relief in the placebo group. Beclomethasone dipropionate was significantly more effective than placebo in reducing symptoms (P
Long-term efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol. [2016]Beclomethasone dipropionate (BDP) nasal aerosol has an established efficacy and safety profile for short-term allergic rhinitis (AR) treatment. However, managing perennial AR (PAR) symptoms often requires long-term treatment. This study evaluates efficacy and safety of long-term treatment with BDP nasal aerosol in PAR patients. In this double-blind, placebo-controlled study, patients (≥12 years [n = 529]) were randomized 4:1 to once-daily treatment with BDP nasal aerosol at 320 μg or placebo. The primary efficacy end point was change from baseline in weekly averages of patient-reported 24-hour reflective total nasal symptom score (rTNSS) over 30 weeks. Safety and tolerability of BDP nasal aerosol were also assessed. Ocular safety, including changes in intraocular pressure and severity of lens opacities (nuclear opalescence, nuclear color, cortical lens opacity, and posterior subcapsular lens opacity), was measured for patients who completed 52 weeks of treatment (n = 245). Across 30 and 52 weeks, BDP nasal aerosol significantly improved rTNSS and instantaneous TNSS (iTNSS) versus placebo (least-squares mean treatment difference, rTNSS, -0.97 for 30 weeks and -1.09 for 52 weeks, p
Metoclopramide Nasal Spray Reduces Symptoms of Gastroparesis in Women, but not Men, With Diabetes: Results of a Phase 2B Randomized Study. [2022]Metoclopramide nasal spray, unlike oral tablets, is absorbed even when patients have delayed gastric emptying or nausea and vomiting. We performed a randomized phase 2b study to evaluate the efficacy and safety of 10-mg and 14-mg metoclopramide nasal spray vs placebo in patients with diabetes and gastroparesis.
Pharmacokinetics and bioavailability of metoclopramide nasal spray versus metoclopramide intravenous in healthy volunteers and cancer patients. [2013]The kinetics and bioavailability of a new formulation of metoclopramide (CAS 364-62-5) nasal spray (MTC NS) were assessed in two separate studies versus the same drug administered intravenously (MTC IV) according to a balanced-block design where each study subject served as his own control. The first study involved 10 healthy subjects, each receiving metoclopramide NS 20 mg (one 10-mg puff per nostril) and metoclopramide IV 20 mg on two trial days separated by a 7-day washout period. On both occasions, blood samples were obtained at time 0 and at 20, 40, 60, 120, 150, 210, 280 and 360 min of dosing. Metoclopramide concentrations were assayed in plasma by HPLC. The second study involved 10 patients of oncologic domain, scheduled to receive mildly emetic chemotherapy regimes. The experimental design was similar to the one above except that blood was sampled at 0, 20, 40 and 60 min and again at 2, 3, 4, 6, and 8 h of dosing. All healthy subjects completed the trial without experiencing any adverse or untoward events; in the group of cancer patients, one subject dropped out after the nose spray treatment when he was removed to another department. This patient was replaced by another, and included in final data analysis only for the segment of treatment actually received. Metoclopramide kinetics after intravenous dosing were in good agreement with known data for the active substance, with no meaningful differences between healthy subjects and cancer patients. With MTC NS administration there was only a slight but significant difference of Cmax, being lower in the cancer patient group (p
Metoclopramide nasal spray in vitro evaluation and in vivo pharmacokinetic studies in dogs. [2018]Metoclopramide (MCP) can effectively alleviate motion sickness-caused nausea and vomiting. Nasal administration offers the greatest patient compliance. It is suitable for self-administration and offers rapid and complete absorption, no first-pass effects and high bioavailability. In the present study, a MCP nasal spray was prepared and evaluated in vitro and in vivo. Nasal cilia toxicity of Bufo toads was used to screen the preservative types and concentrations. Rabbit nasal mucosa was used to evaluate the mucosa permeability of different MCP nasal sprays with different penetration enhancers and preservative. A three-period crossover trial was then carried out in beagle dogs with three different MCP dosage forms: nasal sprays, oral tablets and intramuscular (IM) solution. Liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) was performed to measure dog plasma MCP, and pharmacokinetic parameters were calculated. The results of ciliatoxicity and permeation study showed that 0.03% methyl paraben lacking penetration enhancers was optimal. Compared to control IM, the bioavailability of oral tablets of MCP was 24.9%, while that of nasal spray was 62.3%. Meanwhile time-to-maximal plasma concentration (Tmax) of nasal spray was significantly shorter than that of oral tablets. In conclusion, MCP nasal spray prepared here is safe with minimal ciliatoxicity, rapid onset and high relative bioavailability.