EUCTR2017-000135-14-IT进行中（未招募）1 期
Studio di fase IIa, multicentrico, in doppio cieco, randomizzato, controllato verso placebo, a gruppi paralleli per valutare l'efficacia, la sicurezza e la tollerabilit¿ del trattamento orale con PXT002331 (foliglurax) della durata di 28 giorni nella riduzione delle complicazioni motorie dovute alla terapia con levodopa nei pazienti affetti da malattia di Parkinson che manifestano deterioramento da fine dose e discinesia indotta da levodopa (AMBLED) - AMBLED Study
PREXTON THERAPEUTICS B.V.0 个研究点目标入组 165 人开始时间: 2020年11月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 165
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
- •1. Subjects will be:
- •1.1. males or females of non-childbearing potential diagnosed after the age of 30 years with idiopathic PD (ie, not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) PD Society Brain Bank clinical diagnostic criteria
- •1.2. between 35 and 85 years of age, inclusive, at the time of signing informed consent
- •2. Subjects will have:
- •2.1. a documented medical history of idiopathic PD for at least 3 years
- •2.2. disease severity of 2 to 4 on the modified Hoehn and Yahr scale when in the OFF state
- •2.3. been treated with a stable regimen of levodopa-containing therapy.
- •and should maintain the stability of their therapy throughout the study according to their usual regimen (dose level and frequency). The maximum allowed total levodopa dose must be =1600 mg per day.
- •2.3.1. subjects who are on an immediate-release formulation of levodopa-containing therapy, NOT including Apodespan PR (or equivalent), must be receiving at least 3 doses per day and must be on a stable dose for at least 2 weeks prior to the first screening visit.
- •2.3.2. subjects who are on a long-acting formulation of levodopa-containing therapy, including Apodespan PR (or equivalent), must be on a stable dose for at least 6 weeks prior to the first screening visit
- •2.4. experienced motor fluctuations with wearing off over a period of at least 3 months prior to randomisation, with a minimum daily OFF time of at least 2 hours per 24 hours, while awake (as measured during the Screening Period by subject home diary [Hauser diary] on each of the 3 consecutive days immediately preceding the baseline visit; =2 hours OFF time on each of the 3 days)
- •2.5. experienced predictable OFF periods, as assessed at screening and baseline by a MDS UPDRS Part IV B, Question 4.5 rating of 1 or 2
- •2.6. experienced LID over a period of at least 3 months prior to randomisation, with a minimum daily ON time with dyskinesia
- •(troublesome and/or non troublesome) lasting at least 2 hours per 24 hours, while awake (as measured during the Screening Period by subject home diary [Hauser diary] on each of the 3 consecutive days immediately preceding the baseline visit; =2 hours ON time with dyskinesia on each of the 3 days)
- •2.7. experienced significant time spent with LID, as assessed at screening and baseline by MDS UPDRS Part IV A, Question 4.1 score =1
- •2.8. experienced impact from LID on daily function, as assessed at screening and baseline by MDS UPDRS Part IV A, Question 4.2 score =2
- •2.9. been on a stable regimen of any additional permitted anti-Parkinsonian drugs (ie, peripheral decarboxylase inhibitors, dopamine agonists [except apomorphine], MAO-B inhibitors [except safinamide] or COMT inhibitors) for at least 4 weeks prior to baseline.
- •3. Female subjects will be women of non-childbearing potential, defined as follows:
- •3.1. permanently sterile following hysterectomy, bilateral salpingectomy, bilateral oophorectomy or confirmed tubal occlusion (not tubal ligation)
- •3.2. postmenopausal, defined as at least 12 months post cessation of menses (without an alternative medical cause)
- •3.2.1. postmenopausal status will be confirmed with a screening serum follicle stimulating hormone (FSH) level greater than 40 mIU/mL.
- •4.Subjects must pass a Hauser diary concordance test, defined as at least 75% concordance in ON/OFF ratings between rater and subject over the 4 assessments made over a 2-hour period. Additionally, subjects must be concordant on at
排除标准
- •1.Subjects with atypical, secondary or drug-induced Parkinsonism (eg, metoclopramide, flunarizine), metabolic identified neurogenetic disorders (eg, Wilson's disease), encephalitis, or Parkinson Plus syndromes, or other forms of atypical Parkinsonian syndromes (eg, progressive supranuclear palsy and multiple system atrophy)
- •2.Subjects with a Mini-Mental State Examination (MMSE) score <25
- •3.Subjects who have Long QT syndrome or a QTcF >450 ms (males) or > 470 ms (females) that is considered clinically significant by the Investigator at screening or baseline
- •4.Subjects who have, or who have a history of, any clinically significant hepatic or gallbladder disorder, as determined by the Investigator
- •5.Subjects who have dementia, currently active psychosis or hallucinations. Previous psychotic episodes that were brief and considered drug-induced are not exclusionary; inclusion of such subjects is at the Investigator's discretion.
- •6.Suicide attempt within 1 year prior to the first screening visit, or severe suicidal ideation within 6 months prior to the first screening visit (ie, the subject answers yes to Questions 4 or 5 in the
- •Baseline/Screening C SSRS assessment performed at the first screening visit), or subject is at significant risk of suicidal behaviour in the opinion of the Investigator
- •7.Subject has a current diagnosis of epilepsy, has a history of seizures as an adult, has a history of stroke or has had a transient ischemic attack within 1 year prior to the first screening visit
- •8.Subjects who have a known genetic disorder of human UDP-glucoronosyltransferase
- •9.Any known contraindication to the use of levodopa, including a history of malignant melanoma or a history of narrow-angle glaucoma
- •10.Subject has cancer, with the exception of the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin; cervical carcinoma in situ; prostatic carcinoma in situ; or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years
- •11.Positive serology test (hepatitis B virus surface antigen [HBsAg], hepatitis C virus [HCV] antibody, human immunodeficiency virus [HIV] 1 or 2 antibodies)
- •12.Subjects who have had a clinically significant illness within 4 weeks of first dose, as determined by the Investigator
- •13.Subjects with scheduled surgeries during the study period
- •14.Any advanced, severe or unstable disease (other than PD) that may interfere with the primary and secondary study outcome evaluations
- •15.Subjects who have undergone prior neurosurgical operation for PD or transcranial magnetic stimulation
- •16.Subjects currently taking (or expected to be administered during the course of the study) any of the prohibited medications.
- •17.Subjects who are participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to the baseline visit
- •18.Subjects who have previously taken part in or withdrawn from this study. Re-screening may be permitted on a case-by-case
- •basis based on approval from the Sponsor. Re-screening may only be performed once per subject and applies only to screen failures from the study.
- •19.Male subjects who do not agree to use a barrier method of contraception (ie, a condom with spermicide) in addition to a second highly effective method of contraception used by their female partners or to ref
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