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Low Dose Naltrexone Use in Patients With POTS

StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Jun 2028 to Jun 2029
    • Start date: Jan 2025 to Jul 2026
    • Study completion date: Dec 2028 to Dec 2030
    v7
  2. Primary completion date: Jun 2026 to Jun 2028
    • Start date: Jan 2024 to Jan 2025
    • Study completion date: Dec 2026 to Dec 2028
    v6
  3. Start date: Jun 2023 to Jan 2024v5
  4. Start date: Feb 2023 to Jun 2023v4
  5. Primary completion date: Jun 2025 to Jun 2026
    • Start date: Jun 2022 to Feb 2023
    • Study completion date: Dec 2025 to Dec 2026
    v3
  6. Primary endpoint revised
    • Secondary endpoints: details revised at 1 of 2 entries
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Many patients with Postural Orthostatic Tachycardia Syndrome (POTS) experience debilitating fatigue and this significantly impacts their daily lives. Unfortunately, there are no treatments to help POTS patients with their fatigue. One medication, called low dose naltrexone (LDN), has been tested as a treatment for fatigue in other medical conditions. In this other research, LDN helped patients feel less fatigue. Other research studies have shown that LDN can help reduce markers of inflammation called cytokines. Reducing these cytokines could help reduce symptoms as well. There have been no research studies testing LDN in POTS to date. We are planning to do a research study to test LDN as a treatment to see if it helps POTS patients feel less fatigue.
Trial Details
NCT Number NCT05363514
Lead Sponsor University of Calgary
Conditions
(from sponsor)		 Postural Orthostatic Tachycardia Syndrome
Related terms Postural Orthostatic Tachycardia Syndrome
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov