Clinical Trials


Novus Therapeutics is dedicated to the highest standards in clinical research and keeping the patient and healthcare communities informed about our clinical studies.  For the latest updated information on our clinical studies, please refer to www.clinicaltrials.gov and eudract.ema.europa.eu (for clinical trials conducted in the European Union).

Current Studies


Study OP0201-C-001 (“C-001”) is a phase 1 clinical trial designed to evaluate safety, tolerability, and Eustachian tube (“ET”) function following a single intranasal dose of OP0201 in 16 healthy adults. The randomized, double-blind, placebo-controlled, cross-over trial will explore the effect of a 20 mg dose of OP0201 on ET function. Assessment of ET function will be captured using continuous tympanic impedance while subjects are exposed to changes in atmospheric pressure produced in a hyperbaric/ hypobaric chamber. The single center study will be conducted in Germany. Additional information about the study can be found at clinicaltrials.gov using the identifier NCT03828149.

Study OP0201-C-002 (“C-002”) is a phase 1 clinical trial designed to evaluate safety and tolerability of daily intranasal administration of OP0201 over 14 consecutive days in 30 healthy adults. The randomized, double-blind, placebo-controlled, parallel-group, dose-escalation trial includes a 30 mg per day dose (Cohort A) and 60 mg per day dose (Cohort B) of OP0201. The study is being conducted at a single phase 1 unit in the United States. Additional information about the study can be found at clinicaltrials.gov using the identifier NCT03748758.

Study OP0201-C-004 (“C-004”) is a phase 1 clinical trial designed to evaluate safety, tolerability, and relief of ear pain over a 60-minute observation period following a single intranasal dose of OP0201 in 24 adults with acute otitis media. The randomized, double-blind, placebo-controlled, parallel-group trial will explore the effects of a 20 mg intranasal dose of OP0201. Assessment of pain relief will be captured utilizing a Visual Analog Scale (VAS), Numeric Rating Scale (NRS-11), Patient Global Impression of Change (PGIC), and Clinical Global Impressions Scale: Global Improvement (CGI-I). The multicenter study was conducted in the United States. Additional information about the study can be found at clinicaltrials.gov using the identifier NCT03766373.

Study OP0201-C-006 (“C-006”) is an exploratory phase 2a clinical trial designed to evaluate safety, tolerability, and efficacy of daily intranasal administration of OP0201 over 10 consecutive days in 50 pediatric patients, 6 to 24 months of age, with acute otitis media. The randomized, double-blind, placebo-controlled, parallel-group trial will explore the effects of a 20 mg per day dose of OP0201 as an adjunct to oral antibiotics. Patients will receive 10 days of treatment and will be followed for up to 30 days, during which multiple endpoints will be explored. The single center study will be conducted in the United States. Additional information about the study can be found at clinicaltrials.gov using the identifier NCT03818815.