Efficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Timed Up and Go (TUG) - ON Usual Medication
研究概览
简要总结
The purpose of this study is to explore the efficacy of the drug Amantadine for the treatment of freezing of gait in patients with Parkinson's Disease. The investigators hypothesize that amantadine is useful for management of freezing of gait in subjects with Parkinson's Disease.
详细描述
Subjects who meet the eligibility requirements for the study will be randomized to Amantadine versus a matching placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with idiopathic PD as determined by UK brain bank diagnostic criteria
- •H&Y stage 2.5-3
- •Presence of freezing of gait (FOG) as determined by UPDRS Part I score > 2
- •Ability to walk for 2 minutes in the ON and OFF state
- •Stable regimen of PD medications for 30 days prior to screening
- •Ability to comply with the study procedures
- •If female, be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in Section 6.4.10 for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.
- •Willing and able to provide informed consent.
排除标准
- •Presence of other co morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)
- •Presence of freezing of gait (FOG) ONLY in medications ON state
- •Presence of freezing of gait (FOG) ONLY in medications OFF state
- •Presence of significant cognitive dysfunction as determined by Montreal Cognitive Assessment (MoCA) <20
- •Presence of clinically significant depression as determined by geriatric depression scale (GDS)- 15>5
- •Presence of clinically significant hallucinations
- •Inability to sign informed consent
- •Participation in the physical therapy aimed at management of PD for the duration of the study (PT for orthopedic issues will be allowed)
- •Contraindications for use of Amantadine ( prior history of allergic reaction, history of known renal insufficiency with Cr > 2)
- •If female, be pregnant or lactating
研究组 & 干预措施
Amantadine
Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day
干预措施: Amantadine (Drug)
placebo
Sugar Pill
干预措施: Placebo (Drug)
结局指标
主要结局
Timed Up and Go (TUG) - ON Usual Medication
时间窗: Baseline, change at 4 weeks
This is a walking assessment. The subject will begin in the seated position, stand up, walk 7 meters, turn around, and sit back down. The entire process from leaving the chair to returning to the chair will be timed. Also, the Timed Up and Go (TUG) will be done both in the ON and OFF states.
Timed Up and Go (TUG) - OFF Usual Medication
时间窗: Baseline, change at 4 weeks
This is a walking assessment. The subject will begin in the seated position, stand up, walk 7 meters, turn around, and sit back down. The entire process from leaving the chair to returning to the chair will be timed. Also, the Timed Up and Go (TUG) will be done both in the ON and OFF states.
次要结局
- Freezing of Gait Questionnaire(Baseline, change in 4 weeks)
- Modified Timed Up and Go (mTUG)(Baseline, change in 4 weeks)
- Analysis of Motor Functioning Using the Parkinson's Home Diaries(Baseline, change in 4 weeks)
- Clinical Global Impression (CGI)(4 weeks)
- Parkinson's Disease Questionnaire-39 (PDQ-39)(Baseline, week 4)
- Fatigue Severity Scale (FSS)(Baseline, change in 4 weeks)
- Gait Analysis Testing(Baseline, week 4, week 7, week 11)
- Number Who Completed Medication as Randomized(week 4)
- Number of Participants With Drug Safety Reports(Week 4)
研究者
Tanya Simuni
Professor of Neurology Director, Parkinson's Disease and Movement Disorders Center
Northwestern University