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Theophylline Nasal Spray for Loss of Smell

Phase 1

Waitlist Available

Led By Mara Seier, MD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

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

Must have

Male or female 19-80 years of age

Hoehn and Yahr scale is <3

Must not have

Patients with visible signs of, and/or active symptoms of chronic sinusitis or respiratory infection at Screening or Day 1/Baseline

Severe allergic rhinitis requiring intranasal medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 24

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate whether a nasal spray called intranasal theophylline can improve the sense of smell in individuals with reduced or loss of smell due to the onset of Parkinson's Disease.

Who is the study for?

This trial is for adults aged 19-80 with Parkinson's Disease who have lost their sense of smell or have a reduced ability to smell. Participants will use the study nasal spray twice daily and attend regular check-ups.

What is being tested?

The trial tests if CYR-064, a theophylline-based nasal spray, can improve the sense of smell in those affected by hyposmia or anosmia due to Parkinson's Disease. It involves using the spray over a period of 24 weeks with follow-up visits.

What are the potential side effects?

Potential side effects are not specified but participants will be monitored regularly for any adverse reactions during their bi-weekly and then monthly in-person visits throughout the study.

Eligibility Criteria

Inclusion Criteria

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

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I am between 19 and 80 years old.

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My Parkinson's disease is in the early or mid-stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have visible signs or symptoms of a chronic sinus or respiratory infection.

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I need nasal sprays or drops for my severe allergy symptoms.

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I have a long-term sinus infection, with or without nasal polyps.

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My reduced sense of smell is not due to Parkinson's Disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Numeric Rating Scale-11 Smell-Patient Reported Outcome (PRO) (NRS-11-PRO): Improvement

Numeric Rating Scale-11 Smell-Patient Reported Outcome (PRO) (NRS-11-PRO): Mean Change

Numeric Rating Scale-11 Taste-Patient Reported Outcome (PRO) (NRS-11-PRO): Improvement

+1 more

Secondary study objectives

Cumulative Adverse Events (AEs)

Cumulative Serious Adverse Events (SAEs)

Cumulative Suspected, Unexpected, Serious Adverse Events Related (SUSARs)

Other study objectives

Change in Sniffin' Sticks Threshold, Detection and Identification (TDI) Scores

Correlation of Changes in Numeric Rating Scale-11 Smell-Patient Reported Outcome (PRO) (NRS-11-PRO) Score with Changes in Sniffin' Sticks Threshold Detection and Identification (TDI) Scores

Mean Change in Sniffin' Sticks Threshold, Detection and Identification (TDI) Scores

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intranasal TheophyllineExperimental Treatment1 Intervention

Theophylline Intranasal Spray strength 3.1mg/mL, providing a per spray dose of 140 microgram and total daily dose of 1120 microgram per day (2 sprays per naris BID). Intervention is self-administered.

0 / 6Eligibility criteria met