With limited treatment options and no cure for POTS, the PINNACLE clinical research study is currently underway to investigate potential treatments. Consider the PINNACLE study as an opportunity for your patients with POTS to access emerging treatments.
PINNACLE is a phase 2 clinical study for people with POTS. This study is evaluating if an investigational treatment is safe, well-tolerated, and effective in people with POTS.
The PINNACLE study will take about 18 weeks for each participant to complete. Over the course of the study, the investigational drug or placebo will be administered as a subcutaneous (SC) injection 2 times. The investigational drug is an antibody that targets a cell protein called natriuretic peptide receptor 1 (NPR1), which is found on the surface of different types of cells in the body. Blocking the activity of the NPR1 is expected to increase blood volume and/or blood pressure.
During the study, participants will have approximately 8 on-site study visits. There will be no cost to them for the study treatment, visits, tests, or supplies that are required for the study. They may be compensated for travel and food costs that are related to study visits.
How can you help?
The PINNACLE study is enrolling approximately 81 people with POTS in the United States and Canada. The success of the PINNACLE study depends on referral of potential study participants by physicians. Your patients may be eligible if they:
- Are 18 to 55 years of age at screening visit
- Have ongoing episodic POTS symptoms which have been present for ≥3 months
- Have an increase in HR ≥30 BPM within 10 minutes of changing from supine to a standing position
- Have an absence of orthostatic hypotension (defined as a decrease in SBP >20 mm Hg within 3 minutes of standing)
- Have an absence of other conditions explaining orthostatic tachycardia in the judgment of the investigator
Please note: Other protocol-defined inclusion/exclusion criteria apply.
The study team will check your patient’s full medical history to see if they meet all inclusion criteria and none of the exclusion criteria. Diversity in clinical studies is critical to developing better treatments – help ensure that your patients are represented.
If you have potentially eligible and interested patients, empower them with options and discuss the PINNACLE study. You may also contact the nearest study site to refer them.
Find a study site near you!
Your patient’s health and safety are our top priorities. We hope you value the impact of this research and will consider referring potential candidates. With your support, we hope to help patients with POTS.
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