What side effects are associated with this type of intervention?

Common treatments for reduced sense of smell, particularly post-viral hyposmia, include intranasal sodium citrate solution and olfactory training. Intranasal sodium citrate has been shown to improve olfaction but specific side effects are not detailed in the provided context. Olfactory training, which involves repeated exposure to various odors, generally has no significant adverse effects. Other treatments like clonazepam, used for persistent olfactory disturbances, can cause drowsiness and dizziness. Overall, these treatments are relatively safe with minimal side effects.

What prior FDA approvals exist?

There is limited information on FDA-approved treatments specifically for reduced sense of smell. Treatments such as nasal steroids and certain medications like clonazepam have been used off-label to manage olfactory disturbances, but these are not specifically FDA-approved for this indication. The trial CYR-064's mechanism of action is not specified, making it difficult to directly compare it to existing treatments. Broadly, managing underlying conditions like chronic rhinosinusitis with nasal polyposis using steroids has shown efficacy in improving olfaction.

What other types of research exist?

One promising alternative is (R)-RC-33, a neuroprotective agent acting as a σ₁ receptor agonist, which has shown higher in vitro hepatic metabolic stability and is selected for further in vivo studies in neurodegenerative conditions like amyotrophic lateral sclerosis. Another potential option is PSNCBAM-1, an allosteric antagonist at cannabinoid CB1 receptors, which has shown hypophagic effects and may offer a different pharmacological mechanism with a potentially safer profile.

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CYR-064 for Loss of Smell

Verified Trial

Phase 2

Recruiting

Led By Mas Takashima, MD

Research Sponsored by Cyrano Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female 18-65 years of age.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 32 weeks

Summary

This trial is testing a new treatment called CYR-064 to see if it is safe and works well. About 150 people will take part in the study. The trial will last several months, including initial checks, treatment, and follow-up periods.

Who is the study for?

This trial is for men and women aged 18-65 who've lost their sense of smell but don't have any nasal blockages or diseases causing it. They must be able to take the study drug themselves and follow the trial's procedures.

What is being tested?

The trial tests CYR-064 against a placebo to see if it's safe and works for people with reduced sense of smell. Participants are randomly chosen to receive either CYR-064 or a fake drug, without knowing which one they get.

What are the potential side effects?

Since this summary doesn't provide specific side effects of CYR-064, we can say that potential side effects will be monitored throughout the study as part of assessing the safety of the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 32 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

- Safety and Tolerability

Secondary study objectives

Change in Visual Rating Scale (VRS) scores

Mean Change in NRS-11 Smell-PRO

Mean Change in NRS-11 Taste-PRO

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: CYR-064 dose 2Experimental Treatment1 Intervention

Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.

Group II: CYR-064 dose 1Active Control1 Intervention

Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.

Group III: PlaceboPlacebo Group1 Intervention

Treatment with Placebo nasal solution for 24 weeks. CYR-064 will be self-administered by patients.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for reduced sense of smell include olfactory training, topical treatments, and medications like clonazepam. Olfactory training involves repeated exposure to different odors to stimulate and potentially regenerate olfactory pathways. Topical treatments, such as those containing amitriptyline and ketamine, aim to reduce inflammation and pain, potentially improving olfactory function. Clonazepam, a benzodiazepine, may help by modulating brainstem serotonergic pathways, which can influence sensory processing. These treatments matter for patients as they target different aspects of olfactory dysfunction, offering potential improvements in smell perception and overall quality of life.

Establishing UK research priorities in smell and taste disorders: A James Lind alliance priority setting partnership.Systematic review and meta-analysis of olfactive stimulation interventions to manage procedural pain in preterm and full-term neonates.Flavor education and training in olfactory dysfunction: a pilot study.