Guanfacine and Cromolyn Sodium for POTS: The DBPOTS Trial

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07757555
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Autonomic Nervous System Diseases
  • Dysautonomia
  • Orthostatic Intolerance
  • Postural Orthostatic Tachycardia Syndrome (POTS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Guanfacine (GFC) — DRUG
    Participants receive oral guanfacine for 4 weeks while continuing standardized non-pharmacologic management of POTS. Guanfacine is initiated at 1 mg once daily and may be increased to 2 mg once daily at Week 3 if adequate clinical improvement has not been achieved and the medication is well tolerated. Participants complete symptom assessments and safety evaluations throughout the treatment period.
  • Cromolyn Sodium — DRUG
    Participants receive oral cromolyn sodium for 4 weeks while continuing standardized non-pharmacologic management of POTS. Treatment begins at 200 mg twice daily (400 mg/day) and may be increased to 400 mg twice daily (800 mg/day). For participants who tolerate treatment but have an inadequate response, the dose may be further increased to 1,600 mg/day according to the protocol. Symptom assessments and safety evaluations are performed throughout the treatment period.
  • Placebo — DRUG
    Participants receive matched placebo for 4 weeks while continuing standardized non-pharmacologic management of POTS. Placebo products are matched to the active study medications, including identical dose-escalation procedures, to maintain blinding. Participants complete the same symptom assessments and safety evaluations as during the active treatment periods.

Study Details

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.

Key Dates

First listed
Aug 11, 2026
Start date
Aug 15, 2026
Status verified
Aug 2026
Primary completion
Dec 15, 2027
Completion
Feb 2, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Guanfacine
    Participants receive oral guanfacine during one 4-week treatment period, with dose escalation permitted according to protocol if clinically indicated.
  • Experimental: Cromolyn Sodium
    Participants receive oral cromolyn sodium during one 4-week treatment period, with protocol-defined dose escalation if needed.
  • Placebo Comparator: Placebo
    Participants receive matched placebo during one 4-week treatment period to maintain blinding.

Primary Outcome Measure

Change in Physical Function as Measured by the PROMIS® Physical Function Scale [ Time Frame: Week 0 (baseline), Week 4 (end of treatment), week 10 (end of treatment), week 16 (end of treatment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Malcolm Brock, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins Hospital· Baltimore, MD

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