EUCTR2017-000087-15-ES进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Idiopathic PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD untreated or treated with MAO-B inhibitor
- •- Male or female, 40 to 80 years of age, body weight range of >=45 kg/99 lbs to =< 110 kg/242 lbs and a body mass index (BMI) of 18 to 34 kg/m2
- •- A diagnosis of PD for 2 years or less at screening
- •- H&Y Stage I or II.
- •- A screening brain Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) consistent with PD (central reading)
- •- Clinical status does not require dopaminergic PD medication and is not expected to require dopaminergic treatment within 52 weeks from baseline
- •- If presently being treated for PD, a stable dose of MAO-B inhibitor (rasagiline
- •or selegiline) for at least 90 days prior to baseline and not expected to change within 52 weeks
- •- For women of childbearing potential: use of highly effective contraceptive methods (that result in a failure rate of <1% per year) during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug
- •- For men: use of contraceptive measures as defined below:
- •With female partners of childbearing potential or pregnant female partners, men must use a condom during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The female partners should use a contraception method with a failure rate of <1% per year during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Current or Past Medical History:
- •- Clinical signs or past medical history indicating a Parkinson syndrome other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia.
- •- Known carriers of certain familial PD genes (Parkin, PINK1, DJ1) (GBA, synuclein, LRRK2 mutation carriers are allowed).
- •- History of PD related freezing episodes or falls.
- •- A diagnosis of a significant CNS disease other than Parkinson’s disease; history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child.
- •- Mini Mental State Examination (MMSE) =< 25
- •- Reside in a nursing home or assisted care facility.
- •- History of or screening brain MRI scan indicative of clinically significant abnormality
- •- Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study or interfere with the participant’s ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data:
- •- Autoimmune disease
- •- A history of cancer
- •- Any active infectious disease.
- •- Current, or history of, alcohol or drug abuse or dependence
- •- Any major illness
- •- Any current psychiatric diagnosis
- •- The following cardiovascular conditions:
- •- Myocardial infarction
- •- Confirmed hypotension
- •- Uncontrolled hypertension:
- •- Resting pulse rate (PR) greater than 100 or less than 45 bpm.
- •- Clinically significant cardiovascular disease
- •- Clinically significant abnormalities in lab tests results
- •- Lactating women
- •Medications and treatments:
- •- Prior treatment with dopaminergic medication (e.g., levodopa or a dopaminergic agonist) with no clinical treatment response or a clinical treatment response inconsistent with PD.
- •- Use of any of the following: catechol-O-methyl transferase (COMT) inhibitors (entacapone, tolcapone), amantadine or anticholinergics, or dopaminergic medication (levodopa and both ergot and non-ergot [pramipexole, ropinirole, rotigotine] dopamine agonists) for more than a total of 60 days or within 60 days of baseline.
- •- Anti-epileptic medication for non seizure related treatment which has not remained stable for at least 60 days prior to baseline
- •- Anti-depressant or anxiolytic use that has not remained stable for at least 90 days prior to baseline
- •- Use of any of the following within 90 days prior to baseline; neuroleptics, metoclopramide, alpha methyldopa, clozapine, olanzapine, flunarizine, amoxapine, amphetamine derivatives, reserpine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, and modafinil.
- •- Participated in an investigational drug or device study including prior treatment of PD involving intracranial surgery or implantation of a device
- •- Any prior treatment with an investigational PD-related vaccine
- •- Prior participation in any RO7046015 or PRX002 study.
- •- Receipt of an investigational product or device, or participation in a drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) before baseline
- •- Receipt of a monoclonal antibody or an investigational immunomodulator within 180 days (or 5 half-lives, whichever is longer) before baseline
- •- Systemic corticosteroids or other immunomodulati
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