Theophylline Nasal Spray for PD-Related Hyposmia and Anosmia
NCT06498687 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2025-03-13
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.
Conditions
- Hyposmia
- Anosmia
Interventions
- DRUG
-
CYR-064
Theophylline Nasal Spray
Sponsors & Collaborators
-
University of Nebraska
lead OTHER
Principal Investigators
-
Mara Seier, MD · University of Nebraska
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-30
- Primary Completion
- 2026-06-30
- Completion
- 2026-07-31
- FDA Drug
- Yes
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