2024-516756-18-00招募中3 期
Pharmacologically modulating the noradrenergic arousal system to reduce freezing of gait in Parkinson’s disease: a multi-center and multi-modal approach.
Stichting Radboud universitair medisch centrum2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The effect of atomoxetine vs. placebo on the percentage of time frozen during FOG-provoking gait tasks in the dopaminergic OFF-state.
研究概览
简要总结
To study the effect of atomoxetine FOG severity in the dopaminergic OFF-state.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or older
- •Diagnosis of idiopathic Parkinson's disease according to Movement Disorders Society Diagnostic Criteria
- •Stabilised on optimal dopaminergic treatment for a minimum of four weeks prior to the baseline visit (Visit 1)
- •Presence of freezing of gait symptoms on a daily basis
- •Ability to walk for 10-meters unaided in the dopaminergic ON-state
- •Ability to provide written informed consent in accordance with ICH-GCP and local regulations
- •Willing and able to undergo all clinical trial assessments
排除标准
- •Current and/or previous (within 3 months) participation in a clinical trial
- •(History of) pheochromocytoma
- •Use of noradrenergic agents
- •Use of CYP2D6 inhibitors (SSRIs, quinidine, terbinafine)
- •Use of high dose salbutamol (or other beta2 agonists)
- •Pregnancy and/or breastfeeding
- •Known hypersensitivity to atomoxetine
- •Any contra-indications for undergoing MRI-scanning (e.g. claustrophobia or metal parts within the body such as DBS, an infusion pump or a pacemaker)
- •Co-morbidity that significantly impacts ambulation (e.g. orthopaedic or rheumatological ailments)
- •Severe cognitive impairment hampering the ability to comply with the study protocol
- •Active psychosis that would impact the ability to comply with the study protocol
- •Severe cardiovascular disorders: severe hypertension (Sustained (Sitting) hypertension of ≥180 mmHg systolic or ≥110 mmHg diastolic, defined by the average of three observations, each at least 3 minutes apart, with the participant having assumed the required position for at least 3 minutes), heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias, long QT interval syndrome (QTc > 500ms zettBa-formula) and channelopathies that would significantly compromise participant safety
- •Severe cerebrovascular disorders: cerebral aneurysm or recent/significant stroke
- •Hepatic or renal insufficiency
- •Narrow angle glaucoma
结局指标
主要结局
The effect of atomoxetine vs. placebo on the percentage of time frozen during FOG-provoking gait tasks in the dopaminergic OFF-state.
The effect of atomoxetine vs. placebo on the percentage of time frozen during FOG-provoking gait tasks in the dopaminergic OFF-state.
次要结局
- The effect of atomoxetine vs. placebo on the percentage of time frozen during FOG-provoking gait tasks in the dopaminergic ON-state.
- The effect of atomoxetine vs placebo on brain network topology, as calculated by the average integration/segregation coefficient.
研究者
Franka Goossens
Scientific
Stichting Radboud universitair medisch centrum
研究点 (2)
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