Clinical Trial

Guanfacine and Cromolyn Sodium for POTS: The DBPOTS Trial

Study acronym: DBPOTS
Not Yet Recruiting Early Phase 1
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Summary
The goal of this clinical trial is to learn whether guanfacine or cromolyn sodium can improve symptoms and physical functioning in adults with Postural Orthostatic Tachycardia Syndrome (POTS). Both medications are FDA-approved for other conditions but are investigational for the treatment of POTS. The main questions this study aims to answer are: Does treatment with guanfacine or cromolyn sodium improve physical functioning in adults with POTS compared with placebo? Does treatment with guanfacine or cromolyn sodium improve fatigue, cognitive function ("brain fog"), gastrointestinal symptoms, and overall symptom burden in adults with POTS? Researchers will compare guanfacine, cromolyn sodium, and placebo to determine whether either active treatment provides greater improvement in symptoms and physical functioning than placebo. Participants will: Be randomly assigned to receive guanfacine, cromolyn sodium, and placebo during separate 4-week treatment periods in a randomized, double-blind crossover study. Continue standard non-drug POTS management, including recommendations for fluid and salt intake, exercise, compression garments, and other lifestyle measures. Complete questionnaires that measure physical function, fatigue, cognitive symptoms, gastrointestinal symptoms, and overall health throughout the study. Attend scheduled study visits for safety monitoring and assessment of study outcomes. Provide blood, urine, and sputum samples so researchers can evaluate biomarkers related to POTS and better understand how these treatments may work.
Trial Details
NCT Number NCT07757555
Lead Sponsor Johns Hopkins University
Collaborators: Dysautonomia International
Conditions Postural Orthostatic Tachycardia Syndrome (POTS), Dysautonomia, Orthostatic Intolerance, Autonomic Nervous System Diseases
Enrollment 25 participants
Start Date 2026-08-15
Primary Completion 2027-12-15 (estimated)
Study Completion 2028-02-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-12