Ignite Creation Date:
2024-07-17 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498687
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Theophylline Nasal Spray for PD-Related Hyposmia and Anosmia
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
A Single-Arm Study to Evaluate the Feasibility of CYR-064 Theophylline Nasal Spray for the Treatment of Parkinsons Disease Related Hyposmia and Anosmia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Parkinsons 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 Parkinsons Disease symptoms and ability to detect and identify smells will be completed Participants are monitored for any side effects
Detailed Description:
This is a single-arm study that will investigate the use of intranasal theophylline CYR-064 for the treatment of hyposmia and anosmia related to the onset of Parkinsons disease The study drug of CYR-064 self-administered for a 24-week Treatment Period is intended to improve the sense of smell in participants with persistent hyposmia and anosmia related to the onset of Parkinsons Disease The study population will include approximately 15 adult participants between the ages of 19 to 80 years with moderate to severe hyposmia or anosmia caused by the onset of Parkinsons Disease Eligible participants who meet all study criteria and have consented to participation will receive the investigational new drug CYR-064 with a dose strength of 1120ugday administered for 24 weeks During the 24-week Treatment Period participants will be asked to complete a weekly paper Diary with two questions to monitor compliance to the study drug
Participants will be prompted and instructed to provide responses to 11-point Numeric Rating Scale NRS-11 smell and taste symptom assessments on a scale of 0-10 10 indicating normal senses starting with the baseline visit and then weekly throughout the duration of the study via paper diary Participants will return to the clinic every 2 weeks for the first month of the Treatment Period followed by monthly in-clinic visits thereafter for the assessment of safety and efficacy of CYR-064 at 8 12 16 and 24 weeks
At baseline and week 24 patients will be given the Sniffin Sticks threshold discrimination and identification TDI test
At baseline and week 24 patients will be given the global impression of smell loss severity PGI-SLS smell loss change PGI-SLC global impression of loss of ability to taste food PGI-TS and change in ability to taste food PGI-TC questions note each of these constitutes one multiple choice question
At baseline and week 24 patients will be given the Movement Disorder Society Unified Parkinson Disease Rating Scale MDS-UPDRS parts I and III the Craft Story Recall the Benson Complex Figure Test and the Hopkins Verbal Learning Test - Revised
All participants will have intra-nasal examination and nasal endoscopy performed at baseline and at 24 weeks to ensure no structural or pathological issues are present leading to hyposmia and for assessment of safety Adverse events AE will be assessed through clinical symptom presentation intra-nasal examination and endoscopy
At each monthly in-clinic visit participants will return the vials with the study drug full or empty and receive new vials for use during the following study period Week 24end of study EOS will serve as the last visit for all patients who complete the study followed by a 30-day follow-up Participants who discontinue treatment or study at any time will return to the clinic for the EOS visit At Week 28 7 days a follow-up phone call to assess final safety and efficacy will conclude the participants participation in the study
Participants will be prompted and instructed to provide responses to 11-point Numeric Rating Scale NRS-11 smell and taste symptom assessments on a scale of 0-10 10 indicating normal senses starting with the baseline visit and then weekly throughout the duration of the study via paper diary Participants will return to the clinic every 2 weeks for the first month of the Treatment Period followed by monthly in-clinic visits thereafter for the assessment of safety and efficacy of CYR-064 at 8 12 16 and 24 weeks
At baseline and week 24 patients will be given the Sniffin Sticks threshold discrimination and identification TDI test
At baseline and week 24 patients will be given the global impression of smell loss severity PGI-SLS smell loss change PGI-SLC global impression of loss of ability to taste food PGI-TS and change in ability to taste food PGI-TC questions note each of these constitutes one multiple choice question
At baseline and week 24 patients will be given the Movement Disorder Society Unified Parkinson Disease Rating Scale MDS-UPDRS parts I and III the Craft Story Recall the Benson Complex Figure Test and the Hopkins Verbal Learning Test - Revised
All participants will have intra-nasal examination and nasal endoscopy performed at baseline and at 24 weeks to ensure no structural or pathological issues are present leading to hyposmia and for assessment of safety Adverse events AE will be assessed through clinical symptom presentation intra-nasal examination and endoscopy
At each monthly in-clinic visit participants will return the vials with the study drug full or empty and receive new vials for use during the following study period Week 24end of study EOS will serve as the last visit for all patients who complete the study followed by a 30-day follow-up Participants who discontinue treatment or study at any time will return to the clinic for the EOS visit At Week 28 7 days a follow-up phone call to assess final safety and efficacy will conclude the participants participation in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None