RecruitingRare disease

Study of AGP100 Safety and Effectiveness in Patients with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), a rare heart rhythm disorder that can cause dangerous irregular heartbeats during physical activity or emotional stress. The research evaluates a new medication called DNS-6288 (also known as AGP100) in capsule form, which will be taken orally in addition to standard heart medications.

The main purpose of this research is to determine if DNS-6288 is safe and well-tolerated by patients who have genetically confirmed CPVT and still experience irregular heartbeats during exercise, despite taking their regular medications. The study will test different doses of DNS-6288, with participants receiving up to 50 milligrams per day over a treatment period of 39 weeks.

During the study, participants will undergo regular check-ups that include exercise testing on a bicycle to monitor their heart rhythm. The research team will collect information about any side effects and measure how well the medication works by tracking changes in heart rhythm patterns during exercise. Blood and urine samples will also be collected to understand how the medication works in the body.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
During the first visit, you will undergo a thorough medical examination to confirm your eligibility for participation in the study of AGP100 medication.
You must be between 18 and 75 years old and have a confirmed genetic diagnosis of Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT).
You must be currently taking a stable dose of heart medication (beta-blocker) for at least 4 weeks before starting the study.
Step 2
Baseline assessment
Laboratory tests will be performed, including blood chemistry, blood count, urine analysis, and thyroid function tests.
You will undergo an exercise test on a bicycle to assess your heart rhythm.
Your current symptoms and medical history will be documented.
Step 3
Treatment period
You will receive AGP100 in capsule form to take by mouth.
The treatment period includes visits on Day 1, Day 14, Day 27, Day 39, and Day 68.
During each visit, you will undergo exercise testing and provide blood and urine samples.
Your heart rhythm will be monitored through ECG recordings.
You should avoid strenuous exercise for 24 hours before each study visit.
Step 4
Safety monitoring
Throughout the study, your health will be monitored through regular physical examinations, vital signs checks, and laboratory tests.
Any changes in your condition or side effects will be recorded.
Your medication dose may be adjusted if necessary based on your response to treatment.
Step 5
Study completion
A final assessment will be conducted to evaluate the medication's effects on your heart rhythm during exercise.
Final laboratory tests and physical examination will be performed.
The study will evaluate how well you tolerated the medication and any changes in your exercise-related heart rhythm.

Who can join the trial?

15 criteria

Must sign an informed consent form before any study procedures
Age between 18 and 75 years old
Must have confirmed RYR2 gene mutation and show irregular heart rhythms during exercise
Must be able and willing to perform bicycle exercise tests and show abnormal heart beats during screening
Must be taking a stable dose of beta-blocker medication (a heart medication) for at least 4 weeks before the study starts. If taking nadolol (a specific beta-blocker), it must be taken in the evening
check
Must have normal laboratory test results, including:
- Blood chemistry
- Blood cell counts
- Urine tests
- Thyroid function tests
- Blood clotting tests
- Must agree not to do strenuous or new exercise 24 hours before study visits
- check
  Women who can become pregnant must use highly effective birth control methods throughout the study and for 33 days after, such as:
  - Hormonal contraception (pills, patches, or vaginal rings)
  - Intrauterine devices (IUDs)
  - Permanent sterilization
  - Having a partner who has had a vasectomy

Who cannot join the trial?

13 criteria

Age below 18 years or above 65 years
Pregnant or breastfeeding women
History of severe allergic reactions to medications
Participation in other clinical trials within the past 30 days
Presence of any other significant heart conditions besides Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Inability to perform exercise testing
Unstable medical condition that could interfere with study participation
Known substance abuse or dependence
Mental conditions that could affect ability to provide informed consent
Severe kidney or liver dysfunction
Use of medications that could interact with the study drug AGP100
History of non-compliance with medical treatments
Unable to follow study procedures or attend scheduled visits

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Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

AGP100
is an investigational medication being studied for patients with a rare heart rhythm condition called Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). It is being tested alongside standard care treatments to see if it can help reduce irregular heartbeats that occur during exercise. The medication is currently in early stages of research (Phase 2a) to evaluate its safety and how well patients tolerate it.
Standard of care medications
refers to the current recommended treatments that patients are already taking for their CPVT condition. These typically include beta-blockers and other heart rhythm medications that help control irregular heartbeats.

What is already known about the treatment

AGP100 - An investigational medication currently being studied in Phase 2a clinical trials for the treatment of Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), a rare inherited heart rhythm disorder. The medication is being evaluated as an add-on therapy to current standard treatments in patients who still experience irregular heartbeats during exercise despite existing medication. While the specific mechanism of action and form of administration are not publicly disclosed in the trial information, this experimental drug is being tested for its safety and tolerability at various dose levels in patients with genetically confirmed CPVT. The primary focus of the ongoing clinical research is to determine if AGP100 can safely reduce abnormal heart rhythms in CPVT patients who have not achieved optimal results with conventional treatments.

Investigated diseases

Catecholaminergic Polymorphic Ventricular Tachycardia - A rare inherited heart rhythm disorder that causes irregular heartbeats triggered by physical activity or emotional stress. The condition typically manifests during childhood or adolescence when the heart begins beating chaotically during exercise or intense emotions. During episodes, the heart develops an abnormal rhythm called ventricular tachycardia, where the lower chambers of the heart beat too quickly. The disorder is caused by genetic mutations affecting how the heart cells handle calcium. People with this condition may experience dizziness, light-headedness, or fainting during physical activity or emotional stress.