Theophylline Nasal Spray for PD-Related Hyposmia and Anosmia
NCT Number: NCT06498687
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hyposmia|Anosmia
Interventions: DRUG: CYR-064
Sponsor: University of Nebraska
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-01
Locations: University of Nebraska Medical Center/Nebraska Medicine, Omaha, Nebraska, 68198, United States

Summary:
The goal of this study is to learn if intranasal theophylline (CYR-064) improves sense of smell in participants with hyposmia or anosmia related to the onset of Parkinson's Disease. Fifteen adults, age 19-80, years will participate for about 32 weeks. They will use the study nasal spray for 24 weeks. The nasal spray is given as 2 sprays to each side of the nose twice per day. They will be seen every 2 weeks during the first month of treatment, followed by monthly in-person visits. Tests about memory, Parkinson's Disease symptoms, and ability to detect and identify smells will be completed. Participants are monitored for any side effects.

Primary Outcome Measures: Numeric Rating Scale-11 Smell-Patient Reported Outcome (PRO) (NRS-11-PRO): Improvement, Improvement in patient-reported paper diary (scale 0-10). Score of 0="I cannot smell anything", to 10="My sense of smell is normal to me", baseline to week 24|Numeric Rating Scale-11 Taste-Patient Reported Outcome (PRO) (NRS-11-PRO): Improvement, Improvement in patient-reported paper diary (scale 0-10). Score of 0="I could not taste food", to 10="My food tastes normal to me", baseline to week 24|Numeric Rating Scale-11 Smell-Patient Reported Outcome (PRO) (NRS-11-PRO): Mean Change, Mean Change in patient-reported paper diary (scale 0-10) of sense of smell. Score of 0="I cannot smell anything", to 10="My sense of smell is normal to me", baseline to week 24|Numeric Rating Scale-11 Taste-Patient Reported Outcome (PRO) (NRS-11-PRO): Mean Change, Mean Change in patient-reported paper diary (scale 0-10) of ability to taste food. Score of 0="I could not taste food", to 10="My food tastes normal to me", baseline to week 24
Secondary Outcome Measures: Cumulative Adverse Events (AEs), Cumulative adverse events related to CYR-064, baseline to week 24|Cumulative Serious Adverse Events (SAEs), Cumulative serious adverse events related to CYR-064, baseline to week 24|Cumulative Suspected, Unexpected, Serious Adverse Events Related (SUSARs), Cumulative Suspected, Unexpected, Serious Adverse Events Related to CYR-064, baseline to week 24
Other Outcome Measures: Change in Sniffin' Sticks Threshold, Detection and Identification (TDI) Scores, Individual and cumulative scores of odor threshold, detection and identification. Individual scores of odor threshold, detection and identification which are combined for a global score of olfaction. Scores \<16 indicate anosmia, 16-31 indicate hyposmia and \>31 indicate normosmia., baseline to week 24|Mean Change in Sniffin' Sticks Threshold, Detection and Identification (TDI) Scores, Individual scores of odor threshold, detection and identification which are combined for a global score of olfaction. Scores \<16 indicate anosmia, 16-31 indicate hyposmia and \>31 indicate normosmia., baseline to week 24|Numeric Rating Scale-11 Smell-Patient Reported Outcome (PRO) (NRS-11 Smell Impact-PRO Score), Scale of 0-10 of hyposmia: Score of 0="I cannot smell anything", to 10="My sense of smell is normal to me", baseline to week 24|Patient Global Impression of Smell Loss Severity (PGI-SLS), Patient's description of loss of sense of smell rated as "I have very severe loss of smell", "I have severe loss of smell", "I have moderate loss of smell", "I have mild loss of smell", "I have no loss of smell", baseline to week 24|Patient Global Impression of Smell Loss Change (PGI-SLC), Patient impression of change in sense of smell since starting the study rated as "My sense of smell is much worse now compared to when I started the study", "My sense of smell is worse now compared to when I started the study", "My sense of smell is a little worse compared to when I started the study", "My sense of smell is a little better now compared to when I started the study", "My sense of smell is better now compared to when I started the study", "My sense of smell is much better now compared to when I started the study"., baseline to week 24|Patient Global Impression of Taste (PGI-T-S), Patient Global Impression of Loss of Ability to Taste Food Severity. Rated as "I have very severe loss of taste", "I have severe loss of taste", "I have moderate loss of taste", "I have mild loss of taste", "I have no loss of taste", baseline to week 24|Patient Global Impression of Taste Change (PGI-TC), Patient Global Impression of Change In Ability to Taste Food rated as "My ability to taste food is much worse now compared to when I started the study", "My ability to taste food is worse now compared to when I started the study", "My ability to taste food is a little worse compared to when I started the study", "My ability to taste food is a little better now compared to when I started the study", "My ability to taste food is better now compared to when I started the study", "My ability to taste food is much better now compared to when I started the study"., baseline to week 24|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, Correlation of changes based on patient reported paper diary with clinician administered Sniffin' Sticks, baseline to week 24