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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06019000
Other study ID # CYR-064-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 26, 2023
Est. completion date January 30, 2025

Study information

Verified date December 2023
Source Cyrano Therapeutics, Inc.
Contact Rick Geoffrion
Phone 9258226461
Email Rick@cyranotherapeutics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR-064.


Description:

The purpose of this study is to determine the safety and effectiveness of CYR-064 in a randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR064. The study will take approximately 32 weeks which will include a 4-week screening period to evaluate if participants are right for the Study, followed by a 24-week Treatment Period, and a 1 week follow up after participants have completed the Study. About 150 subjects will participate in this study in about 25 research sites in the United States.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date January 30, 2025
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Able to provide written informed consent. - Male or female 18-65 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. - Any concomitant medical condition that in the opinion of the Investigator, compromises patient safety or compliance with the study protocol or collected data. - History of moderate to severe Substance Use Disorder within the past 3 years as assessed by the Investigator. - History of persistent chronic sinusitis without polyps or chronic sinusitis with polyps. - Use or planned use of tobacco or nicotine-containing products, including smoking, smokeless tobacco, e-cigarettes, or nicotine replacement products within 3 months prior to Screening through EOS. - Unwilling or unable to discontinue current or planned use of over the counter or prescription medication administered intranasally, with the exception of nasal saline. - Use or planned use of another investigational drug within 4 weeks prior to Screening through Follow-Up. - Receiving any concomitant medication/therapy that would, in the opinion of the Investigator, compromise patient safety or compliance with the study protocol or collected data. - General Exclusions Any female who is pregnant, planning to become pregnant during the study, or who is lactating. Vulnerable patients. Any condition or abnormality (including clinical laboratory, physical examination, or vital sign abnormalities), current or past, that, in the opinion of the Investigator, would compromise the efficacy evaluation, safety of the patient, or would interfere with or complicate study procedures or assessments.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
CYR-064
CYR-064 is a nasal solution.

Locations

Country Name City State
United States Centers for Advanced ENT Baltimore Maryland
United States Specialty Physician Associates Bethlehem Pennsylvania
United States ENTAAFL Boca Raton Florida
United States Medical University of South Carolina-MUSC Charleston South Carolina
United States Rush University Medical Center Chicago Illinois
United States Colorado ENT & Allergy Colorado Springs Colorado
United States Houston Methodist Houston Texas
United States KU Medical Center-University of Kansas Kansas City Kansas
United States Advanced ENT and Allergy Louisville Kentucky
United States Kentuckian ENT Louisville Kentucky
United States Tandem Clinical Research Marrero Louisiana
United States Charleston ENT and Allergy North Charleston South Carolina
United States ENTAAFL Plantation Florida
United States ENTAAFL Port Saint Lucie Florida
United States Ear Nose Throat & Allergy Associates Puyallup Washington

Sponsors (1)

Lead Sponsor Collaborator
Cyrano Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

Henkin RI, Abdelmeguid M. Improved Smell and Taste Dysfunction with Intranasal Theophylline. Am J Otolaryngol Head Neck Surg. 2019;2(9):1070.

Henkin RI, Hosein S, Stateman WA, Knoppel AB, Abdelmeguid M. Improved smell function with increased nasal mucus sonic hedgehog in hyposmic patients after treatment with oral theophylline. Am J Otolaryngol. 2017 Mar-Apr;38(2):143-147. doi: 10.1016/j.amjoto — View Citation

Henkin RI, Levy LM, Fordyce A. Taste and smell function in chronic disease: a review of clinical and biochemical evaluations of taste and smell dysfunction in over 5000 patients at The Taste and Smell Clinic in Washington, DC. Am J Otolaryngol. 2013 Sep-O — View Citation

Henkin RI, Schultz M, Minnick-Poppe L. Intranasal theophylline treatment of hyposmia and hypogeusia: a pilot study. Arch Otolaryngol Head Neck Surg. 2012 Nov;138(11):1064-70. doi: 10.1001/2013.jamaoto.342. — View Citation

Henkin RI, Velicu I, Schmidt L. An open-label controlled trial of theophylline for treatment of patients with hyposmia. Am J Med Sci. 2009 Jun;337(6):396-406. doi: 10.1097/MAJ.0b013e3181914a97. — View Citation

Henkin RI, Velicu I, Schmidt L. Relative resistance to oral theophylline treatment in patients with hyposmia manifested by decreased secretion of nasal mucus cyclic nucleotides. Am J Med Sci. 2011 Jan;341(1):17-22. doi: 10.1097/MAJ.0b013e3181f1fdc8. — View Citation

Henkin RI, Velicu I. cAMP and cGMP in nasal mucus related to severity of smell loss in patients with smell dysfunction. Clin Invest Med. 2008;31(2):E78-84. doi: 10.25011/cim.v31i2.3367. — View Citation

Henkin RI. Comparative monitoring of oral theophylline treatment in blood serum, saliva, and nasal mucus. Ther Drug Monit. 2012 Apr;34(2):217-21. doi: 10.1097/FTD.0b013e3182492a20. — View Citation

Henkin RI. Growth Factors in Olfaction. In: Preedy VR, editor. Handbook of Growth and Growth Monitoring in Health and Disease. New York, NY: Springer New York; 2012. p. 1417-36.

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Outcome - Safety and Tolerability The count and percentage of patients reporting AEs, SAEs, and SUSARs will be summarized overall, by System Organ Class, Preferred Term within the System Organ Class, maximum severity, and relationship to study drug. All other safety parameters, including clinical laboratory values through blood draws, will be summarized using descriptive statistics for continuous variables and counts and percentages for categorical variables. All changes in nasal mucosal appearance will be noted. Approximately 32 weeks
Secondary Secondary Outcome-improvement on NRS-11 Smell-PRO Improvement in patient reported NRS-11 Smell-PRO (scale of 0-10) in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24. Approximately 24 weeks
Secondary Secondary Outcome-improvement on NRS-11 Taste-PRO Improvement in patient reported NRS-11 Taste-PRO (scale of 0-10) in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24. Approximately 24 weeks
Secondary Secondary Outcome-Mean Change in NRS-11 Smell-PRO Mean Change in NRS-11 Smell-PRO from Baseline to Week 24 between CYR-064 low and high dose and placebo from Baseline to Week 24 Approximately 24 weeks
Secondary Secondary Outcome-Mean Change in NRS-11 Taste-PRO Mean Change in NRS-11 Taste-PRO from Baseline to Week 24 between CYR-064 low and high dose and placebo from Baseline to Week 2 Approximately 24 weeks
Secondary Change in Visual Rating Scale (VRS) scores Change in Visual Rating Scale (VRS) scores in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24.
VRS high dose versus placebo
VRS low dose versus placebo
VRS low and high dose combined versus placebo
Approximately 24 weeks
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