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Enrollment change, Trial termination: A Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous TRV250 (clinicaltrials.gov) - Sep 22, 2021 P1, N=9, Terminated, N=360 --> 9 | Recruiting --> Terminated; Because there have been significant enrollment struggles which has been exacerbated by the COVID impact. This has caused an undue delay to the study timelines and its enrollment goals beyond the business needs.
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Clinical, PK/PD data, Journal: A Phase I, Randomized, Single‑Blind, Placebo‑Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist, in Healthy Subjects. (Pubmed Central) - Aug 20, 2021 This has caused an undue delay to the study timelines and its enrollment goals beyond the business needs. The findings from the first-in-human study support further evaluation of TRV250, a G-protein selective DOR agonist, in the treatment of acute migraine.
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