In what situations might an open-label trial be the only feasible design?

Triheptanoin dramatically reduced by 90% the number of non-epileptic paroxysmal manifestations over 2 months in GLUT1-DS and improved patient's brain energy ... Carefully designed open-label clinical trials may deliver valuable, high-quality clinical data that can advance the drug development process. Conclusions: These data suggest that ligands for the gamma subtype of PPARs may represent a novel therapy for ulcerative colitis. A double blind, placebo- ... Donepezil is an effective and safe drug for the long-term symptomatic treatment of mild to moderately severe AD for up to 144 weeks (2.8 years). For this reason, extreme care needs to be taken regarding how subjects are randomized in open-label trials and randomization methods should be clearly explained ... NCI's Dictionary of Cancer Terms provides easy-to-understand definitions for words and phrases related to cancer and medicine. An open-label randomised-controlled trial of azathioprine vs. mycophenolate mofetil for the induction of remission in treatment-naive autoimmune hepatitis. Nov 2, 2023 ... Interim Analyses from the Beacon Trial: A Phase 2, Randomized, Open-Label Trial of Bitopertin in Erythropoietic Protoporphyria. Gayle Ross ... A multicenter, single-arm, open-label trial of birociclib, a CDK4/6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast ... Oct 30, 2019 ... The study included children aged between 8 and 17 years, with moderate to severe psoriasis, given tofacitinib 5 mg orally twice daily for at least 36 weeks.