Treatment of two mitochondrial disease patients with a combination of febuxostat and inosine that enhances cellular ATP.
Naoyuki Kamatani, Akifumi Kushiyama, Licht Toyo-Oka...
https://pubmed.ncbi.nlm.nih.gov/30631120Actively Recruiting
Phase 1
Age: 18Years - 80Years
All Genders
ID07170475
A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
Led by Fujita Health University · Updated on 2025-09-12
24
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of taking combined febuxostat and inosine orally twice daily in adults with early-stage Parkinson's disease who are on stable medication regimens. This Phase Ib trial involves 24 participants to assess safety over a 12-week period. The study aims to gather important safety data to guide future Parkinson's disease treatments. Participants are randomly assigned to one of four dose levels of febuxostat and inosine, taken twice a day (morning and evening) for 12 weeks. Each participant receives their assigned dose orally and follows the same dosing schedule throughout the study. During the trial, participants will visit the clinic at the start and at weeks 4, 8, and 12 for blood tests, physical exams, and questionnaires. They will also keep a simple diary to record any side effects or changes in daily activities. Researchers will primarily measure changes in plasma hypoxanthine levels and monitor Parkinson's disease symptoms and cognitive function using established scales. The total participation duration is approximately 12 weeks.
CONDITIONS
Brief Title
A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Able to provide voluntary written informed consent.
- Receiving stable Parkinson's disease medication with no changes in type or dose for at least 3 months before enrollment.
- Age 18 to 80 years at the time of consent.
- Diagnosed with Parkinson's disease by a specialist using MDS-PD diagnostic criteria.
- Hoehn-Yahr stage (ON state) between 1 and 3.
- MDS-UPDRS Part III (ON state) score between 10 and 35.
- Mini-Mental State Examination (MMSE) score of 24 or higher.
You will not qualify if you...
- Requires almost total assistance in daily life and cannot walk or stand unaided.
- Currently taking azathioprine, mercaptopurine hydrate, vidarabine, didanosine, or rosuvastatin.
- Used febuxostat, allopurinol, or topiroxostat within 3 months before study start.
- Taking any supplement containing inosine.
- Started any new Parkinson's disease medication or therapy within 3 months before enrollment.
- Serum creatinine greater than 1.5 times upper limit of normal or AST (GOT) or ALT (GPT) greater than 2 times upper limit of normal at screening.
- History of surgical treatment for Parkinson's disease.
- History of or allergy to any ingredient of the investigational drugs.
- Participation in another clinical trial involving an unapproved drug within 30 days before consent or currently enrolled in another interventional study.
- Pregnant or breastfeeding, or unwilling or unable to use reliable contraception during the study.
- Positive test at screening for HIV, HBV, HTLV-1, or syphilis; HCV antibody-positive with undetectable HCV RNA is allowed.
- Unable to take the investigational drugs orally without changing the dosage form.
- Gastrointestinal disease or prior GI surgery that may affect drug absorption.
- Psychiatric disorder or symptoms that interfere with daily life and make study participation difficult.
- Unable to complete assessments or questionnaires independently.
- Any other condition that would make participation unsafe or inappropriate as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants take febuxostat and inosine tablets orally twice daily for 12 weeks according to their assigned dose level.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Fujita Health University
Toyoake, Aichi-ken, Japan, 470-1192
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Shortage of Cellular ATP as a Cause of Diseases and Strategies to Enhance ATP.
Todd A Johnson, H A Jinnah, Naoyuki Kamatani
https://pubmed.ncbi.nlm.nih.gov/30837873Uric acid and alterations of purine recycling disorders in Parkinson's disease: a cross-sectional study.
Sayuri Shima, Yasuaki Mizutani, Junichiro Yoshimoto...
https://pubmed.ncbi.nlm.nih.gov/39251680Improved Parkinsons disease motor score in a single-arm open-label trial of febuxostat and inosine.
Hirohisa Watanabe, Tatsuya Hattori, Akito Kume...
https://pubmed.ncbi.nlm.nih.gov/32871874