Interventional, Randomized, Double-blind, Placebo-controlled Three-way Crossover Study Investigating the Pharmacodynamic Effects of Two Doses of Foliglurax Using Electroencephalography in Patients With Parkinson's Disease and in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Power in the frequency domain of the greater tremor frequency
研究概览
简要总结
The purpose of this study is to investigate effects of foliglurax on brain wave patterns (electric signals) in healthy subjects and in patients with PD
详细描述
All Treatment Periods (P1 to P3) consist of 7 days of dosing (D1 to D7) with either:
- 10 mg foliglurax bis in die (BID) (treatment A)
- 30 mg foliglurax BID (treatment B)
- Placebo BID (treatment C)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •The subject has an acceptable resting EEG at the Screening Visit, as judged by the investigator
- •The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
- •Patients with PD
- •The patient has an acceptable resting EEG performed at the screening period, as judged by the investigator.
- •The patient is, in the opinion of the investigator, fit for enrolment in the study based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
- •The patient has been diagnosed with idiopathic PD for ≥3 years, with a current disease severity of 2 to 4 on the modified Hoehn and Yahr scale in the 'off' state.
- •The patient has dyskinesia that is not too severe to cause discomfort for the patient during the EEG assessments
- •Exclusion criteria:
- •The subject has taken disallowed medication <1 week prior to the first dose of Investigational Medicinal Product (IMP) or <5 half-lives prior to the Screening Visit for any medication taken.
- •The subject has significant alcohol consumption
- •The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP.
- •The subjects has a known genetic disorder of human UDPglucoronosyltransferase
- •The subject is pregnant or breastfeeding.
- •Other in- and exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
Healthy
干预措施: Foliglurax 10 mg (treatment A) (Drug)
Healthy
干预措施: Foliglurax 30 mg (treatment B) (Drug)
Healthy
干预措施: Placebo (treatment C) (Drug)
PD
干预措施: Foliglurax 10 mg (treatment A) (Drug)
PD
干预措施: Foliglurax 30 mg (treatment B) (Drug)
PD
干预措施: Placebo (treatment C) (Drug)
结局指标
主要结局
Power in the frequency domain of the greater tremor frequency
时间窗: From baseline to Day 7 in each Treatment Period
Power in micro-volts squared
Latency of EEG movement related desynchronization of the μ-oscillations
时间窗: From baseline to Day 7 in each Treatment Period
Latency of μ-desynchronization ipsilateral and contralateral (in ms)
Latency of EEG movement related synchronization of the beta-oscillations
时间窗: From baseline to Day 7 in each Treatment Period
Latency of beta-rebound ipsilateral and contralateral (in ms)
Offset of EEG movement related synchronization of the beta-oscillations
时间窗: From baseline to Day 7 in each Treatment Period
Offset of beta-rebound ipsilateral and contralateral (in ms)
Latency of movement from cue measured by accelerometer
时间窗: From baseline to Day 7 in each Treatment Period
Latency of movement from cue (in ms)
Average power in u-desynchronization cluster measured by EEG
时间窗: From baseline to Day 7 in each Treatment Period
Power in μ-desynchronization cluster ipsilateral and contralateral (in micro-volts squared)
Average power in beta-rebound cluster measured by EEG
时间窗: From baseline to Day 7 in each Treatment Period
Power in beta-rebound cluster ipsilateral and contralateral (in micro-volts squared)
次要结局
未报告次要终点