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NCT06498687
A Single-Arm Study to Evaluate the Feasibility of CYR-064 Theophylline Nasal Spray for the Treatment of Parkinson's Disease Related Hyposmia and Anosmia
Phase 1 trial testing CYR-064 in Hyposmia. Withdrawn.
1 June 2026
Quick facts
| Lead sponsor | University of Nebraska |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 April 2025 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 July 2026 |
Drugs / interventions tested
- CYR-064 — full drug profile →
Conditions studied
Sponsor
University of Nebraska
Who can join
Adults 19 to 80, any sex, with Hyposmia or Anosmia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Numeric Rating Scale-11 Smell-Patient Reported Outcome (PRO) (NRS-11-PRO): Improvement
Time frame: baseline to week 24
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" -
Numeric Rating Scale-11 Taste-Patient Reported Outcome (PRO) (NRS-11-PRO): Improvement
Time frame: baseline to week 24
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" -
Numeric Rating Scale-11 Smell-Patient Reported Outcome (PRO) (NRS-11-PRO): Mean Change
Time frame: baseline to week 24
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" -
Numeric Rating Scale-11 Taste-Patient Reported Outcome (PRO) (NRS-11-PRO): Mean Change
Time frame: baseline to week 24
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"
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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The Nasal-Brain Drug Delivery Route: Mechanisms and Applications to Central Nervous System Diseases.
Qiu Y, Huang S, Peng L, Yang L, et al · · 2025 · cited 18× · PMID 40487748 · DOI 10.1002/mco2.70213
Verify or expand the search:
- PubMed search for NCT06498687
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CYR-064
Trials testing the same drug.
- NCT06019000 — Study of CYR-064 Versus Placebo in Patients. · Phase 2 · completed
Other recruiting trials for Hyposmia
Currently open trials in the same condition.
- NCT06733636 — Scents of Progress: Leveraging a Novel Device for Olfactory Training in Older Adults · NA · recruiting
- NCT06817499 — Treatment of Olfactory Dysfunction Using Vagus Nerve Stimulation · NA · active not recruiting
- NCT05364125 — Olfactory Training on Smell Dysfunction Patients in HK · NA · recruiting
Other University of Nebraska trials
Trials by the same sponsor.
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- NCT07506993 — Inflammation in Clear Aligners With and Without Attachments · not yet recruiting
- NCT07207850 — Parents Helping Parents for Youth Vaping Cessation · NA · not yet recruiting
- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06498687 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Nebraska
- Last refreshed: 12 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06498687.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing