NCT04647877 - 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)

Kopsky DJ, Keppel Hesselink JM, Russell AL, Vrancken AFJE
No Detectable Phenytoin Plasma Levels After Topical Phenytoin Cream Application in Chronic Pain: Inferences for Mechanisms of Action. J Pain Res. 2022 Feb 9;15:377-383. doi: 10.2147/JPR.S345347. eCollection 2022.
Kopsky DJ, Keppel Hesselink JM
Phenytoin Cream for the Treatment for Neuropathic Pain: Case Series. Pharmaceuticals (Basel). 2018 May 28;11(2):53. doi: 10.3390/ph11020053.
Kopsky DJ, Keppel Hesselink JM
Single-Blind Placebo-Controlled Response Test with Phenytoin 10% Cream in Neuropathic Pain Patients. Pharmaceuticals (Basel). 2018 Nov 12;11(4):122. doi: 10.3390/ph11040122.
Kopsky DJ, Vrancken AFJE, Keppel Hesselink JM, van Eijk RPA, Notermans NC
Usefulness of a Double-Blind Placebo-Controlled Response Test to Demonstrate Rapid Onset Analgesia with Phenytoin 10% Cream in Polyneuropathy. J Pain Res. 2020 May 1;13:877-882. doi: 10.2147/JPR.S243434. eCollection 2020.

Enrichment Randomized Double-blind, Placebo-controlled Cross-over Trial With PHEnytoin Cream in Patients With Painful Chronic Idiopathic Axonal polyNEuropathy

Details for clinical trial NCT04647877

Clinical trial NCT04647877 - References