NCT03890315 - 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)

Adam A, Dixon AK, Gillard JH, Schaefer-Prokop C, Grainger RG, Allison DJ
Grainger & Allison's Diagnostic Radiology E-Book: Elsevier Health Sciences; 2014.
Attal N, Lanteri-Minet M, Laurent B, Fermanian J, Bouhassira D
The specific disease burden of neuropathic pain: results of a French nationwide survey. Pain. 2011 Dec;152(12):2836-43. doi: 10.1016/j.pain.2011.09.014. Epub 2011 Oct 20.
Holbech JV, Bach FW, Finnerup NB, Jensen TS, Sindrup SH
Pain phenotype as a predictor for drug response in painful polyneuropathy-a retrospective analysis of data from controlled clinical trials. Pain. 2016 Jun;157(6):1305-13. doi: 10.1097/j.pain.0000000000000563.
Magerl W, Krumova EK, Baron R, Tölle T, Treede RD, Maier C
Reference data for quantitative sensory testing (QST): refined stratification for age and a novel method for statistical comparison of group data. Pain. 2010 Dec;151(3):598-605. doi: 10.1016/j.pain.2010.07.026. Epub 2010 Oct 20.
Vollert J, Maier C, Attal N, Bennett DLH, Bouhassira D, Enax-Krumova EK, Finnerup NB, Freynhagen R, Gierthmühlen J, Haanpää M, Hansson P, Hüllemann P, Jensen TS, Magerl W, Ramirez JD, Rice ASC, Schuh-Hofer S, Segerdahl M, Serra J, Shillo PR, Sindrup S, Tesfaye S, Themistocleous AC, Tölle TR, Treede RD, Baron R
Stratifying patients with peripheral neuropathic pain based on sensory profiles: algorithm and sample size recommendations. Pain. 2017 Aug;158(8):1446-1455. doi: 10.1097/j.pain.0000000000000935.

Evaluation of Patients With Neuropathic Pain in the Context of Clinical Symptoms, Quantitative Sensory Tests and Imaging With FMRI

Clinical trial NCT03890315 - References