Effect of Rasagiline on Balance in Parkinson's Disease as Measured by Computerized Posturography
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Computerized Dynamic Posturography Strategy Composite Score
研究概览
简要总结
This study evaluates the effect of rasagiline on balance in Parkinson's disease. Participants taking study medication which is rasagiline or sugar pill will undergo a computerized balance test on and off medication. Participants will stand on a platform which which moves slightly and a computer will measure their body sway and provide a balance score.
详细描述
The study will test the hypothesis that therapy with rasagiline improves balance in PD patients as measured by computerized dynamic posturography. 5 subjects will be randomized to rasagiline or placebo and 5 further subjects will be randomized to rasagiline as adjuvant therapy versus placebo. Subjects will be analyzed by computerized dynamic posturography testing. The device measures body sway under varying visual and vestibular cues and is used for assessment of balance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or above
- •Clinical diagnosis of Parkinson disease by verified by movement disorders expert at the initial study visit with at least two cardinal signs of the disease (rest tremor, bradykinesia, rigidity, and postural instability).
- •For the monotherapy arm, patients must not be on amantadine, dopamine agonists, or levodopa. For the adjuvant therapy arm: Patients must be on a stable dose of their current medication for treatment of Parkinson disease which may include any combination of the following: amantadine, trihexiphenydil, dopamine agonist, and/or levodopa.
- •Patients may continue their stable dose of tricyclic, selective serotonin reuptake inhibitor, or serotonin norepinephrine reuptake inhibitor if they are on these medications at randomization.
排除标准
- •Catechol-O-Methyltransferase (COMT) inhibitor therapy use 30 days prior to start of study (both study arms).
- •Dopamine receptor blocker use (such as quetiapine) one week prior to taking study drug
- •For both monotherapy and adjuvant therapy arms: use of MAO inhibitor therapy including selegiline or rasagiline within 30 days prior to taking study drug and first posturography evaluation.
研究组 & 干预措施
Rasagiline monotherapy
Participants will be taking rasagiline 1 mg oral tablet daily
干预措施: computerized dynamic posturography (Diagnostic Test)
Rasagiline monotherapy
Participants will be taking rasagiline 1 mg oral tablet daily
干预措施: Rasagiline 1 mg capsule (Drug)
placebo monotherapy
Participants will be taking placebo 1 mg orally daily.
干预措施: computerized dynamic posturography (Diagnostic Test)
placebo monotherapy
Participants will be taking placebo 1 mg orally daily.
干预措施: Placebo (Drug)
rasagiline adjuvant therapy
Participants will be taking rasagiline 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication.
干预措施: computerized dynamic posturography (Diagnostic Test)
rasagiline adjuvant therapy
Participants will be taking rasagiline 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication.
干预措施: Rasagiline 1 mg capsule (Drug)
placebo adjuvant therapy
Participants will be taking placebo 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication.
干预措施: computerized dynamic posturography (Diagnostic Test)
placebo adjuvant therapy
Participants will be taking placebo 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication.
干预措施: Placebo (Drug)
结局指标
主要结局
Computerized Dynamic Posturography Strategy Composite Score
时间窗: 8 weeks
Change from baseline to week 8 measurement of Computerized Dynamic Posturography Strategy Composite Score will be compared among the 4 arms of the study.
次要结局
未报告次要终点
研究者
Robert Fekete
Associate Professor
New York Medical College