ISRCTN73371260已完成2 期
A phase II, placebo controlled, double blind, randomised clinical trial to assess the safety and tolerability of 30mg/kg daily ursodeoxycholic acid (UDCA) in patients with Parkinson’s disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32759251/ (added 27/04/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37246815/ (added 13/10/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of Parkinson’s disease =3 years ago by a clinician with particular expertise in the diagnosis and treatment of movement disorders
- •2. Subjective improvement of motor impairment on dopaminergic medication, confirmed by PI through personal examination and/or review of medical records
- •3. Hoehn and Yahr stage =2.5 in the practically-defined on medication state. This implies that all patients will be mobile without assistance during their best on” medication periods.
- •4. Ability to take the study drug
- •5. Ability to communicate in English
- •6. Aged 18-75 years
- •7. Documented informed consent to participate
- •8. Able to comply with study protocol and willing to attend necessary study visits
排除标准
- •1. Diagnosis or suspicion of other cause of parkinsonism. Patients with clinical features indicating a diagnosis of progressive supranuclear palsy (PSP), multiple systems atrophy (MSA), drug induced-parkinsonism, dystonic tremor or essential tremor will not be recruited.
- •2. Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/31P-MRS acquisition
- •3. Known claustrophobia or other reasons why patient could not tolerate or be suitable for 31P-MRS
- •4. Current or previous exposure to UDCA
- •5. Current or previous diagnosis of liver disease, in particular PBC judged to be significant by the clinical investigator
- •6. Prior intracerebral surgical intervention for PD (including deep-brain stimulation). Patients who have previously undergone deep brain stimulation, intracerebral administration of growth factors, gene therapies or cell therapies will not be eligible.
- •7. Already actively participating in a trial of a device, drug or surgical treatment for PD
- •8. History of alcoholism
- •9. Women of child-bearing potential (WOCBP)
- •10. Participants who lack the capacity to give informed consent
- •11. Any medical or psychiatric condition which in the investigator’s opinion compromises the potential participant’s ability to participate
- •12. Concurrent dementia defined by a score lower than 25 on the Montreal Cognitive assessment (MoCA)
- •13. Concurrent severe depression defined by a score > 16 on the Montgomery-Asberg Depression Rating Scale (MADRS)
- •14. Serum transaminases more than 2 times upper limit of normal
- •15. Using ciclosporin, nitrendipine or dapsone for the treatment of concomitant, general medical conditions
研究者
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