Phase 2 study of oral semaglutide tablet for patients with Parkinson's disease
- Conditions
- D010300Parkinson's disease
- Registration Number
- JPRN-jRCT2051230090
- Lead Sponsor
- Kimura Yasuyoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 99
1) Aged 20-80 years at the time of informed consent
2) Diagnosed with PD by a neurologist [In terms of diagnosis, meet the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria (UKPDSBB criteria) International Parkinson and Movement Disorder Society (MDS) Clinical Diagnostic criteria (MDS-PD criteria, clinically established PD) or MDS-early PD criteria]
3) On-time Modified Hoehn and Yahr classification <=2.5
4) Receiving stable PD medication for 4 weeks prior to V1. For MAO-B inhibitors, stable dose and dosage for 12 weeks prior to V1.
5) With written informed consent
1) Diagnosed or supected with Parkinson's syndrome other than PD
2) Familial PD
3) Showing abnormalities with brain MRI or CT that may affect DaTscan results
4) Cannot come to the hospital in an off-state
5) Moderate-severe depression with PHQ-9>=16
6) Cognitive dysfunction with MMSE<=23 or FAB<=11
7) Receiving device aided therapy, previous history of irreversible brain surgery, previous history of gene therapy or cell transplantation as PD treatment
8) Currently participating in another investigational study and previously participated in investigational study of disease-modifying therapies
9) Body mass index<18.5
10) Type1 or Type2 diabetes mellitus
11) Severe gastrointestinal disorder, severe Gastro esophageal reflux disease and previous history of gastrectomy
12) Previous history of Pancreatitis
13) Kidney dysfunction with eGFR<30mL/min
14) Decompensated cirrhosis
15) Diagnosed or supected Thyroid tumor
16) Previous history or family history of Multiple endocrine neoplasia type2
17) Pregnant, breastfeeding and unable to contraception during the study period
18) Receiving medication to be taken upon waking and unable to change or discontinue during the study period
19) Eat, drink, or take oral medication within 8 hours prior to taking the study drug
20) Previous use of GLP-1 receptor agonists, including semaglutide
21) Answer yes to item 4 or item 5 of the C-SSRS suicidal ideation. Current or past suicidal behavior or received treatment for suicidal attempts or plans
22) Unable to DaTscan due to alcohol sensitivity
23) Other, unqualified for this study decided by investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in clinically defined off-state MDS-UPDRS part 3 score at 48week
- Secondary Outcome Measures
Name Time Method Efficacy and Safety