Parkinson's Disease (PD)Phase 1iFRESH-PDNCT07170475
A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
A Phase 1 study testing Febuxostat and Inosine in people with Parkinson's Disease (PD), run by Fujita Health University at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- Febuxostat and Inosine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 27 Jun 2025to 31 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide voluntary written informed consent.
- Receiving stable Parkinson's disease medication (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 according to MDS-PD diagnostic criteria, and at pre-enrollment screening, all of the following are met:
- Hoehn-Yahr stage (ON state) 1 to 3
- MDS-UPDRS Part III (ON state) score 10 to 35
- Mini-Mental State Examination (MMSE) score ≥ 24
Who cannot join
- Requires almost total assistance in daily life and is unable to 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 >1.5× upper limit of normal (ULN), or AST (GOT) or ALT (GPT) >2× ULN at screening.
Show all 16Show fewer
- History of surgical treatment for Parkinson's disease.
- History of or comorbid hypersensitivity/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/unable to use reliable contraception during the study period.
- 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, as judged by the investigator.
- 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, in the investigator's judgment, would make participation unsafe or inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Fujita Health University
Toyoake, Aichi-ken, 470-1192
Keiko Uesugi, Registered Nurse, 81-562-93-9362, kuesugi@fujita-hu.ac.jp
Hirohisa Watanabe, MD. PhD.
About this study
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.
Read more
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
- Parkinson's Disease (PD)
- Being tested
- Febuxostat, Inosine
- Keywords
- Parkinson Disease, Febuxostat, Inosine, Hypoxanthine, Combination Therapy, Safety Study
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FebuxostatDrug
Febuxostat tablets (per randomized assignment), administered orally twice daily (once in the morning and once in the evening) for 12 weeks.
InosineDrug
Inosine tablets (per randomized assignment), administered orally twice daily (once in the morning and once in the evening) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Febuxostat + Inosine （Dose Level 1) | Experimental | Participants receive febuxostat and inosine (Dose Level 1) orally, twice daily (once in the morning and once in the evening) for 12 weeks. Receives: Drug: Febuxostat; Drug: Inosine |
| Group 2 - Febuxostat + Inosine (Dose Level 2) | Experimental | Participants receive febuxostat and inosine (Dose Level 2) orally, twice daily (once in the morning and once in the evening) for 12 weeks. Receives: Drug: Febuxostat; Drug: Inosine |
| Group 3 - Febuxostat + Inosine (Dose Level 3) | Experimental | Participants receive febuxostat and inosine (Dose Level 3) orally, twice daily (once in the morning and once in the evening) for 12 weeks. Receives: Drug: Febuxostat; Drug: Inosine |
| Group 4 - Febuxostat + Inosine (Dose Level 4) | Experimental | Participants receive febuxostat and inosine (Dose level 4) orally, twice daily (once in the morning and once in the evening) for 12 weeks. Receives: Drug: Febuxostat; Drug: Inosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma hypoxanthine concentration from baseline to Week 12
The difference in plasma hypoxanthine level (µmol/L) between pre-dose at Day 0 and Week 12 visit.
Measured: 12 weeks
Secondary outcomes (5)
Change in plasma hypoxanthine concentration from baseline to Week 4
The difference in plasma hypoxanthine level between pre-dose at Day 0 and Week 4 visit.
Measured: 4 weeks
Change in cerebrospinal fluid (CSF) hypoxanthine concentration from baseline to Week 12
The difference in CSF hypoxanthine level between the pre-dose at Day 0 and the Week 12 visit.
Measured: 12 weeks
Change in MDS-UPDRS Part III score from baseline to Week 12
The difference in Movement Disorder Society-Unified Parkinson's Disease Rating Scale motor examination (ON state) score between Day 0 and Week 12.
Measured: 12 weeks
Change in Mini-Mental State Examination (MMSE) score from baseline to Week 12
The difference in MMSE score between Day 0 and Week 12.
Measured: 12 weeks
Change in Geriatric Depression Scale-15 (GDS-15) score from baseline to Week 12
The difference in GDS-15 score between Day 0 and Week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start27 Jun 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in parallel to one of four dose-combination groups and receive their assigned regimen twice daily for 12 weeks. Dosing is open-label, with febuxostat co-administered with inosine each morning and evening. Safety and pharmacodynamic blood measures are collected at baseline and at weeks 4, 8, and 12.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujita Health University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170475
- Sponsor's protocol ID
- FU-PD-i01
- Acronym
- iFRESH-PD
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including the dataset and data dictionary) and the whole study protocol will be made available to qualified researchers beginning 6 months after publication and ending 3 years after publication. Requests should be directed to the corresponding author, Dr. Hirohisa Watanabe (email: hirohisa.watanabe@fujita-hu.ac.jp), with a research proposal and data use agreement. IPD Sharing Time Frame: Available 6 months to 3 years after publication. IPD Sharing Access Criteria: Qualified researchers with IRB/ethics approval and a signed data use agreement.
Publications
Kamatani N, Hashimoto M, Sakurai K, Gokita K, Yoshihara J, Sekine M, Mochii M, Fukuuchi T, Yamaoka N, Kaneko K. Clinical studies on changes in purine compounds in blood and urine by the simultaneous administration of febuxostat and inosine, or by single administration of each. Gout and Nucleic Acid Metabolism. 2017;41 (2): 171-181.
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.
PubMed 30631120Johnson 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.
PubMed 30837873Shima 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.
PubMed 39251680Watanabe 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.
PubMed 32871874
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07170475
- Acronym / sponsor ID
- iFRESH-PD / FU-PD-i01
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson Disease, Febuxostat, Inosine, Hypoxanthine, Combination Therapy, Safety Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fujita Health UniversityUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants are randomized in parallel to one of four dose-combination groups and receive their assigned regimen twice daily for 12 weeks. Dosing is open-label, with febuxostat co-administered with inosine each morning and evening. Safety and pharmacodynamic blood measures are collected at baseline and at weeks 4, 8, and 12.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Febuxostat + Inosine （Dose Level 1) | Experimental | Drug: Febuxostat, Drug: InosineParticipants receive febuxostat and inosine (Dose Level 1) orally, twice daily (once in the morning and once in the evening) for 12 weeks. |
| Group 2 - Febuxostat + Inosine (Dose Level 2) | Experimental | Drug: Febuxostat, Drug: InosineParticipants receive febuxostat and inosine (Dose Level 2) orally, twice daily (once in the morning and once in the evening) for 12 weeks. |
| Group 3 - Febuxostat + Inosine (Dose Level 3) | Experimental | Drug: Febuxostat, Drug: InosineParticipants receive febuxostat and inosine (Dose Level 3) orally, twice daily (once in the morning and once in the evening) for 12 weeks. |
| Group 4 - Febuxostat + Inosine (Dose Level 4) | Experimental | Drug: Febuxostat, Drug: InosineParticipants receive febuxostat and inosine (Dose level 4) orally, twice daily (once in the morning and once in the evening) for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to provide voluntary written informed consent.
- Receiving stable Parkinson's disease medication (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 according to MDS-PD diagnostic criteria, and at pre-enrollment screening, all of the following are met:
Key exclusion criteria (16 listed)
- Requires almost total assistance in daily life and is unable to 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FebuxostatFebuxostat tablets (per randomized assignment), administered orally twice daily (once in the morning and once in the evening) for 12 weeks. | Drug | Group 1 - Febuxostat + Inosine （Dose Level 1), Group 2 - Febuxostat + Inosine (Dose Level 2), Group 3 - Febuxostat + Inosine (Dose Level 3), Group 4 - Febuxostat + Inosine (Dose Level 4) |
| InosineInosine tablets (per randomized assignment), administered orally twice daily (once in the morning and once in the evening) for 12 weeks. | Drug | Group 1 - Febuxostat + Inosine （Dose Level 1), Group 2 - Febuxostat + Inosine (Dose Level 2), Group 3 - Febuxostat + Inosine (Dose Level 3), Group 4 - Febuxostat + Inosine (Dose Level 4) |
Primary outcome
Change in plasma hypoxanthine concentration from baseline to Week 12
Time frame: 12 weeks
The difference in plasma hypoxanthine level (µmol/L) between pre-dose at Day 0 and Week 12 visit.
5 secondary outcomes
Change in plasma hypoxanthine concentration from baseline to Week 4
Time frame: 4 weeks
Change in cerebrospinal fluid (CSF) hypoxanthine concentration from baseline to Week 12
Time frame: 12 weeks
Change in MDS-UPDRS Part III score from baseline to Week 12
Time frame: 12 weeks
Change in Mini-Mental State Examination (MMSE) score from baseline to Week 12
Time frame: 12 weeks
Change in Geriatric Depression Scale-15 (GDS-15) score from baseline to Week 12
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publicationKamatani N, Hashimoto M, Sakurai K, Gokita K, Yoshihara J, Sekine M, Mochii M, Fukuuchi T, Yamaoka N, Kaneko K. Clinical studies on changes in purine compounds in blood and urine by the simultaneous administration of febuxostat and inosine, or by single administration of each. Gout and Nucleic Acid Metabolism. 2017;41 (2): 171-181.
- Results publication: PubMed 30631120Kamatani 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.
- Results publication: PubMed 30837873Johnson 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.
- Results publication: PubMed 39251680Shima 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.
- Results publication: PubMed 32871874Watanabe 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including the dataset and data dictionary) and the whole study protocol will be made available to qualified researchers beginning 6 months after publication and ending 3 years after publication. Requests should be directed to the corresponding author, Dr. Hirohisa Watanabe (email: hirohisa.watanabe@fujita-hu.ac.jp), with a research proposal and data use agreement. IPD Sharing Time Frame: Available 6 months to 3 years after publication. IPD Sharing Access Criteria: Qualified researchers with IRB/ethics approval and a signed data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Febuxostat and Inosine in people with Parkinson's Disease (PD), run by Fujita Health University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma hypoxanthine concentration from baseline to Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07170475, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.