EUCTR2010-022517-25-DE进行中（未招募）1 期
Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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. willing and able to provide written informed consent
- •2. age 30 to 75 years, inclusive
- •3. outpatient with idiopathic PD according to the UK Parkinson's Disease
- •Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC)
- •4. on an optimized PD treatment regimen with a stable dose of antiparkinsonian
- •medication for at least four weeks before the Screening
- •Visit (levodopa, DDIs, COMT inhibitors, dopamine agonists and MAO-B
- •inhibitors).
- •5. treated with a daily L-dopa dose (immediate or extended release
- •formulation) between 300 and 1500 mg divided into a minimum of three
- •doses per day
- •6. experiences dyskinesia for at least three months prior to study entry
- •7. experiences moderately disabling dyskinesia (screening visit UPDRS
- •33 score = 2)
- •8. has an mAIMS score at baseline = 7 with a score = 3 in at least one
- •9. has the ability to communicate adequately with the study staff and to comply with the requirements of the entire study, with the help of a
- •carer if applicable
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. has more than 4 hours, i.e. 8 missing or incorrectly completed entries
- •in the Screening diary
- •2. surgical treatment for Parkinson's disease (e.g. Deep Brain
- •Stimulation, within the last year or planned during the study)
- •3. unstable co-existing psychiatric disease including cognitive
- •impairment that, according to the Investigator, could interfere with the
- •conduct of the study
- •4. has a known clinically significant allergy or known hypersensitivity to
- •drugs that, in the opinion of the Investigator, may affect the patient's
- •5. has clinically significant abnormal laboratory parameters at screening,
- •in particular, liver or renal functions tests greater than 1.5 times the
- •upper limit of normal (ULN) or any other clinically significant
- •biochemical or hematological abnormality as determined by the
- •Investigator
- •6. is taking or has taken less then 4 weeks prior to Screening excluded
- •drugs: NMDA antagonists including amantadine and memantine as well
- •as amphetamines, cocaine, topiramate, sodium valproate, apomorphine,
- •MAO-A inhibitors, dopamine antagonists including metoclopramide,
- •phenothiazines and any antipsychotics, potent inhibitors of CYP1A2, i.e.
- •fluvoxamine or fluoroquinolone antibiotics, potent inhibitors of CYP2C8,
- •i.e. gemfibrozil.
- •7. has known or suspected human immunodeficiency virus (HIV) or
- •hepatitis B or C.
- •8. has a history of a significant medical condition that may affect the
- •safety of the patient or preclude adequate participation in the study,
- •including but not limited to orthostatic hypotension causing syncope,
- •uncontrolled ischemic heart disease, uncontrolled brady- or
- •tachyarrhythmias, coronary obstructive pulmonary disease, chronic
- •obstructive pulmonary disease, arrhythmias, diabetes and epilepsy.
- •9. is pregnant or breast-feeding. Female patients who are of childbearing
- •potential must be using adequate contraceptive methods (e.g.
- •oral contraceptive, double-barrier method, intra-uterine device, intramuscular
- •hormonal contraceptive), and have a negative pregnancy test
- •at Screening.
- •10. has received any investigational drug within 30 days of Screening.
研究者
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