Study of CYR-064 Versus Placebo in Patients. (NCT06019000) | Clinical Trial Compass
CompletedPhase 2
Study of CYR-064 Versus Placebo in Patients.
United States151 participantsStarted 2023-09-26
Plain-language summary
Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR-064.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able to provide written informed consent.
* Male or female 18-70 years of age.
* Endoscopy of the nasal cavity showing no structural or pathologic issues leading to hyposmia (nasal polyps, sinusitis, infection, etc.) that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors.
* CT scan of the nasal cavity after the onset of hyposmia (within prior 2 years) prior to Baseline showing no structural or pathologic issue leading to hyposmia that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors.
* Willing and able to self-administer the study drug, follow the study drug administration instructions, comply with study procedures, and participate in the scheduled study visits specified in this protocol.
Exclusion Criteria:
* History of traumatic brain injury, Parkinson's disease, early dementia, Alzheimer's disease, or any other condition in which hyposmia is not expected to improve in the opinion of the Investigator, such as history of congenital or idiopathic hyposmia or a surgical procedure that led to hyposmia.
* History of surgery that led to hyposmia.
* Concomitant Medical Conditions
* Current symptoms or signs of an acute respiratory viral illness at Screening or Baseline.
* Chronic viral infection or immunodeficiency condition (e.g., medical history of human immunodeficiency virus) based on medical records.
* Any active malignancy.
* A…