NCT03681080 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Anderson JW, Lambert EA, Sari CI, Dawood T, Esler MD, Vaddadi G, Lambert GW
Cognitive function, health-related quality of life, and symptoms of depression and anxiety sensitivity are impaired in patients with the postural orthostatic tachycardia syndrome (POTS). Front Physiol. 2014 Jun 25;5:230. doi: 10.3389/fphys.2014.00230. eCollection 2014.
Arnold AC, Haman K, Garland EM, Raj V, Dupont WD, Biaggioni I, Robertson D, Raj SR
Cognitive dysfunction in postural tachycardia syndrome. Clin Sci (Lond). 2015 Jan;128(1):39-45. doi: 10.1042/CS20140251.
Gibbons CH, Centi J, Vernino S, Freeman R
Autoimmune autonomic ganglionopathy with reversible cognitive impairment. Arch Neurol. 2012 Apr;69(4):461-6. doi: 10.1001/archneurol.2011.2372. Epub 2011 Dec 12.
Guaraldi P, Poda R, Calandra-Buonaura G, Solieri L, Sambati L, Gallassi R, Cortelli P
Cognitive function in peripheral autonomic disorders. PLoS One. 2014 Jan 17;9(1):e85020. doi: 10.1371/journal.pone.0085020. eCollection 2014.
Maier A, Schopen L, Thiel JC, Muller K, Fimm B, Schulz JB
Cognitive functioning in postural orthostatic tachycardia syndrome among different body positions: a prospective pilot study (POTSKog study). Clin Auton Res. 2023 Jun 1. doi: 10.1007/s10286-023-00
Stewart JM, Del Pozzi AT, Pandey A, Messer ZR, Terilli C, Medow MS
Oscillatory cerebral blood flow is associated with impaired neurocognition and functional hyperemia in postural tachycardia syndrome during graded tilt. Hypertension. 2015 Mar;65(3):636-43. doi: 10.1161/HYPERTENSIONAHA.114.04576. Epub 2014 Dec 15.

Understanding Impaired Concentration, Attentional Deficits and Their Pathophysiology in Postural Orthostatic Tachycardia Syndrome (POTS) and Other Autonomic Neuropathies (POTSKog-Study Aachen)

Details for clinical trial NCT03681080

Clinical trial NCT03681080 - References