臨床研究等提出・公開システム

A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients with Parkinson's Disease

iFRESH-PD Trial

Hirohisa Watanabe

Fujita Health University Hospital

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aich

hirohisa.watanabe@fujita-hu.ac.jp

Yukiko Moriguchi

Fujita Health University

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aich

+81-562-93-9576

yukiko.moriguchi@fujita-hu.ac.jp

Not Recruiting

June. 20, 2025

Interventional

randomized controlled trial

open(masking not used)

dose comparison control

parallel assignment

other

(1) Patients who have given voluntary written consent to participate in this clinical trial
(2) Patients who have been taking concomitant Parkinson's disease medication for at least 3 months prior to enrollment without any changes or discontinuation of the type or dose
(3) Patients who have been taking concomitant Parkinson's disease medication for at least 3 months prior to enrollment without any changes or discontinuation
(4) Age:18 to 80 years (as of the date of consent)
(5) Patients who have been diagnosed with Parkinson's disease by a specialist based on the MDS-PD diagnostic criteria and who meet all of the following criteria at the time of pre-enrollment testing
1) Hoehn-Yahr severity classification (ON state) 1 to 3
2) MDS-UPDRS Part III (ON state) score 10 to 35
3) MMSE score 24 or higher

(1) Patients who require almost total assistance in daily life and are unable to walk or stand without assistance
(2) Patients taking azathioprine, mercaptopurine hydrate, vidarabine, didanosine, or rosuvastatin
(3) Patients who have used febuxostat, allopurinol, or topiroxostat within 3 months prior to the start of the study
(4) Patients taking supplements containing inosine
(5) Patients who have started new Parkinson's disease medications and therapies within 3 months prior to enrollment
(6) Patients with serum creatinine exceeding 1.5 times the upper limit of normal in pre-enrollment tests, or AST (GOT) or ALT (GPT) Patients with more than twice the upper limit of normal range
(7) Patients who have undergone surgery for Parkinson's disease
(8) Patients with a history of or comorbid hypersensitivity or idiosyncrasies (allergies) to the ingredients of the investigational drug
(9) Patients who have participated in other clinical trials or clinical studies within 30 days of obtaining consent and have been administered unapproved drugs, or patients currently participating in other clinical trials or clinical studies
(10) Patients who are pregnant or may be pregnant, breastfeeding patients, or patients who cannot agree to contraception during the study period. (Note that it is recommended that a reliable method of contraception be used, such as using multiple oral contraceptives or contraceptive devices (condoms, intrauterine devices, etc.) approved or certified in Japan.)
(11) Patients who test positive for any of the infectious disease-related tests (HIV, HBV, HCV*1, HTLV-1, syphilis) in the pre-registration test (Visit 1)
*1: Patients with positive HCV antibodies but no detectable HCV RNA will not be excluded.
(12) Patients who cannot take the investigational drug orally without changing its dosage form.
(13) Patients with a digestive system disease or history of digestive surgery that the investigator (subinvestigator) judges may affect the absorption of the investigational drug.
(14) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and are deemed difficult to participate in the study.
(15) Patients who have difficulty answering the assessment scales or questionnaires by themselves.
(16) Patients who the investigator (subinvestigator) judges to be otherwise inappropriate for participation in the clinical trial.

Parkinson's disease

Patients were randomly assigned to one of the following treatment groups and received the dose orally twice daily:
Group 1: Febuxostat 20 mg, Inosine 200 mg
Group 2: Febuxostat 20 mg, Inosine 600 mg
Group 3: Febuxostat 20 mg, Inosine 800 mg
Group 4: Febuxostat 30 mg, Inosine 600 mg

change of hypoxanthin in plasma from 0 to 12 weeks

+81-562-93-2873

Dec. 27, 2024

No

none