Novus Therapeutics is committed to conducting ethical and scientifically rigorous clinical studies. We believe that it is important to keep study participants, patients, healthcare practitioners and investors informed regarding study design and status of our active clinical studies, as well as results for completed studies. Copies of the current protocol synopsis (describing the design of the study) for all active studies are available on our website. Information on the status of our clinical studies can be found at www.clinicaltrials.gov and eudract.ema.europa.eu (for clinical trials conducted in the European Union). Copies of the results for completed studies are also available on our website (e.g., poster presentations, publications, reports).
Active Clinical Studies
Study OP0201-C-006 (“C-006”) is an exploratory phase 2a clinical study designed to evaluate safety, tolerability, and efficacy of daily intranasal administration of OP0201 or placebo over 10 consecutive days in up to approximately 140 pediatric patients, 6 to 24 months of age, with acute otitis media. The randomized, double-blind, placebo-controlled, parallel-group study explores the effects of 20 mg per day of OP0201 as an adjunct to oral antibiotics. Study Participants will receive 10 days of treatment and will be followed for up to 30 days, during which multiple endpoints will be explored. Additional information about the study can be found by clicking the box above “Read the Study Protocol Synopsis” and at clinicaltrials.gov using the identifier NCT03818815.
Publications & Presentations
A phase 1 safety study of repeated doses of intranasal OP0201 metered dose inhaler compared to placebo in healthy adults: a potential treatment for otitis media. Presented at the International Society for Otitis Media’s 20th International Symposium on Recent Advances in Otitis Media; June 9–13, 2019; Los Angeles, CA.
Comparison of safety and efficacy of foam-based versus solution-based ciprofloxacin for acute otitis externa; Otolaryngology Head and Neck Surgery 143(4):492-9 · October 2010