EUCTR2022-002988-30-DE招募中1 期
Double-blind, randomised, prospective, placebo controlled parallel group phase II study to investigate the effect of glycerol phenylbutyrate (GPB) on neurofilament light chain (NfL) levels in patients with corticobasal syndrome (CBS) - PROFI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age: = 18 years
- •2. „clinical possible or „clinical probable CBS (Armstrong et al., Neurol-ogy, 2013 80;496-503) and patients with Progressive Supranuclear Palsy-CBS according to Höglinger et al. (Mov Disord. 2017 Jun;32(6):853-864)
- •3. No regular consumption of glycerol phenylbutyrate within the last 6 months prior to V1
- •4. Capable of thoroughly understanding all information given and giving full informed consent according to GCP
- •5. Capability and willingness to comply with the procedures of the clini-cal trial
- •6. Women of childbearing age must be non-lactating and surgically ster-ile or using a highly effective method of birth control and have a nega-tive pregnancy test. In case of using a hormonal contraception, the method must be sup-plemented with a barrier method (preferably male condom). Acceptable methods of birth control with a low failure rate i.e. less than 1% per year when used consistently and cor-rect are such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence (defined as refraining from heterosexual intercourse during the clinical trial) or vasecto-mized partner. Unacceptable birth control methods are: periodic abstinence (calen-dar, symptothermal, post-ovulation methods), withdrawal (coitus inter-ruptus), spermicides only and lactational amenorrhoea method (LAM). Female condom and male condom should not be used together.
- •7. A stable regimen for at least 1 month prior to V1 and no foreseeable need to change the regimen throughout the 26 week treatment period for
- •a. drugs acting against Parkinsonism (e.g. Levodopa, Dopa-mine-Agonists, Amantadine and MAO-B-Inhibitors)
- •b. other CNS-active substances including e.g. antidepressants and antidementia drugs
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1. Neurodegenerative diseases other than CBS
- •2. Underlying Alzheimer’s pathology as defined by positive ß-amyloid-PET or reduced Aß 1-42 in CSF
- •3. Participation in another clinical trial involving administration of an in-vestigational medicinal product within 1 month or 5 half-lives of the investigational medicinal product, whichever is longer, prior to V1
- •4. Known hypersensitivity to glycerol phenylbutyrate or its further components, or to drugs with a similar chemical structure or to any of the components of the placebo
- •5. Treatment with valproic acid, haloperidol or probenecid
- •6. A physical or psychiatric condition (e.g. frontal lobe syndrome, psychotic disorder or major depression), which at the investigator’s discre-tion may put the subject at risk, may confound the trial results or may interfere with the subject’s participation in this clinical trial
- •7. Persistent abuse of medication, drugs or alcohol
- •8. Current or planned pregnancy or breast-feeding in females
- •9. Other severe medical conditions upon the discretion of the investiga-tor
研究者
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