Recruiting · registry statusEarly safety testing of two medicines taken together
Researchers test the safety and tolerability of febuxostat and inosine together as a possible approach for Parkinson’s.
Testing a treatment or activity · Study reference: NCT07170475
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.
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Results reported
- Start (reported actual date)
- 2025-06-27
- Main measurements finished (planned)
- 2026-03-31
- Study finished (planned)
- 2026-07-31
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
Kamatani N, Kushiyama A, Toyo-Oka L, Toyo-Oka T. Treatment of two mitochondrial disease patients with a combination of febuxostat and inosine that enhances cellular ATP. J Hum Genet. 2019 Apr;64(4):351-353. doi: 10.1038/s10038-018-0558-0. Epub 2019 Jan 10. ↗
Registry results reference
Johnson TA, Jinnah HA, Kamatani N. Shortage of Cellular ATP as a Cause of Diseases and Strategies to Enhance ATP. Front Pharmacol. 2019 Feb 19;10:98. doi: 10.3389/fphar.2019.00098. eCollection 2019. ↗
Registry results reference
Shima S, Mizutani Y, Yoshimoto J, Maeda Y, Ohdake R, Nagao R, Maeda T, Higashi A, Ueda A, Ito M, Mutoh T, Watanabe H. Uric acid and alterations of purine recycling disorders in Parkinson's disease: a cross-sectional study. NPJ Parkinsons Dis. 2024 Sep 9;10(1):170. doi: 10.1038/s41531-024-00785-0. ↗
Registry results reference
Watanabe H, Hattori T, Kume A, Misu K, Ito T, Koike Y, Johnson TA, Kamitsuji S, Kamatani N, Sobue G. Improved Parkinsons disease motor score in a single-arm open-label trial of febuxostat and inosine. Medicine (Baltimore). 2020 Aug 28;99(35):e21576. doi: 10.1097/MD.0000000000021576. ↗
Registry results reference
Who can join?
Ages 18 years to 80 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
Inclusion Criteria:
1. Able to provide voluntary written informed consent.
2. Receiving stable Parkinson's disease medication (no changes in type or dose) for at least 3 months before enrollment.
3. Age 18 to 80 years at the time of consent.
4. Diagnosed with Parkinson's disease by a specialist according to MDS-PD diagnostic criteria, and at pre-enrollment screening, all of the following are met:
1. Hoehn-Yahr stage (ON state) 1 to 3
2. MDS-UPDRS Part III (ON state) score 10 to 35
3. Mini-Mental State Examination (MMSE) score ≥ 24
Exclusion Criteria:
1. Requires almost total assistance in daily life and is unable to walk or stand unaided.
2. Currently taking azathioprine, mercaptopurine hydrate, vidarabine, didanosine, or rosuvastatin.
3. Used febuxostat, allopurinol, or topiroxostat within 3 months before study start.
4. Taking any supplement containing inosine.
5. Started any new Parkinson's disease medication or therapy within 3 months before enrollment.
6. Serum creatinine \>1.5× upper limit of normal (ULN), or AST (GOT) or ALT (GPT) \>2× ULN at screening.
7. History of surgical treatment for Parkinson's disease.
8. History of or comorbid hypersensitivity/allergy to any ingredient of the investigational drugs.
9. Participation in another clinical trial involving an unapproved drug within 30 days before consent, or currently enrolled in another interventional study.
10. Pregnant or breastfeeding, or unwilling/unable to use reliable contraception during the study period.
11. Positive test at screening for HIV, HBV, HTLV-1, or syphilis; \*\*HCV antibody-positive with undetectable HCV RNA\*\* is allowed.
12. Unable to take the investigational drugs orally without changing the dosage form.
13. Gastrointestinal disease or prior GI surgery that may affect drug absorption, as judged by the investigator.
14. Psychiatric disorder or symptoms that interfere with daily life and make study participation difficult.
15. Unable to complete assessments or questionnaires independently.
16. Any other condition that, in the investigator's judgment, would make participation unsafe or inappropriate.
Full study name & original research details
Official study title
A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
Original description
This study will test the safety of twice-daily oral dosing of combined febuxostat and inosine in 24 patients with Parkinson's disease. Participants will receive one of the four regimens, taken twice daily for 12 weeks:
Who can join: Adults with early-stage Parkinson's disease on stable medication regimens.
What participants do:
* Take their assigned dose twice daily (morning and evening) for 12 weeks.
* Visit the clinic at baseline and weeks 4, 8, and 12 for blood tests (including hypoxanthine), exams, and questionnaires.
* Keep a simple diary of any side effects or changes in daily activities.
Risks and benefits: Possible side effects include mild gastrointestinal upset, headache, or elevated uric acid levels. While direct benefit is not guaranteed, this safety data will inform future Parkinson's disease treatments.
Learn more: Contact \[site-specific contact info\] for details on eligibility and enrollment.
Conditions reported: Parkinson's Disease (PD)
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- Febuxostat; Inosine
- Phases
- PHASE1
- Sponsor
- Fujita Health University
- Start date reported by registry
- 2025-06-27 (actual)
Registry updated: 2025-09-12 · Status last verified by the registry submitter: 2025-09
Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
No central contact is listed. Check the location contacts or the official registry record.
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Fujita Health University
Toyoake, Aichi-ken, Japan
RecruitingKeiko Uesugi, Registered Nurse · 81-562-93-9362 · kuesugi@fujita-hu.ac.jp
Hirohisa Watanabe, MD. PhD.
The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.