A Prospective Randomized Placebo-Controlled Double-Blind Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic Parkinson's Disease
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline in UPSIT score at 10-week visit
研究概览
简要总结
A decrease or loss of the sense of smell is very common in patients with Parkinson's Disease even in the earliest stages of the disease. There have been no treatments that have been proven to improve sense of smell in patients with Parkinson's Disease.
Rasagiline (brand name: Azilect) was approved by the U.S. Food and Drug Administration (FDA) on May 16th 2006 to be used by Parkinson's patients to treat the motor symptoms associated with the disease. The purpose of this study is to see if there is change in sense of smell after starting Rasagiline.
详细描述
This study will last approximately 10 weeks.
- 2 visits to The Parkinson's Institute in Sunnyvale, California
- 1 phone call between visits
You will be asked to take either Rasagiline (Azilect) or placebo (an identical pill without active ingredients)
- 5 in 6 chance of receiving Rasagiline (Azilect)
- 1 in 6 chance of receiving placebo
- Neither you nor the study team will know which you are assigned
- This information will be available in case of emergency
To be eligible for this study, you must:
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
- — 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with Parkinson's Disease (PD), defined as the presence of at least two of the cardinal signs of PD (bradykinesia, resting tremor, rigidity) without other identifiable cause of parkinsonism or signs of atypical parkinsonism
- •Functional hyposmia or anosmia, as defined by UPSIT scores less than the 25th percentile for age- and gender-matched norms
- •Have been on stable dose of PD medications for at least 30 days
- •Age < or = 90 years
- •Willing and able to give informed consent
- •Women of child-bearing potential may participate provided they are willing to use adequate contraceptive methods during the duration of the study. Women of childbearing potential must have a negative pregnancy test at the screening visit and be non-lactating.
排除标准
- •Prior use of an MAO inhibitor, including selegiline or rasagiline within the last 12 months
- •Presence of other conditions that in the investigator's opinion may significantly cause olfactory impairment, including prior head trauma, nasal surgery, nasal inflammation causing concurrent congestion or polyps, nasal or sinus infection, prior intranasal zinc salt (Zicam) use, history of smoking within the past year
- •Presence of dementia or significant cognitive impairment with Mini-Mental State Examination (MMSE) < 24
- •Present of a medical or surgical condition which in the opinion of the investigator would preclude participation in and completion of study procedures
- •Use of any experimental medication within 60 days of baseline
- •Use of decongestants, antihistamines, inhaled steroids within 2 weeks of baseline
- •Use of any medication contraindicated with use of rasagiline (Investigator will take into consideration concomitant antidepressant use as per prescribing information guidelines for rasagiline)
研究组 & 干预措施
Rasagiline
0.5mg of Rasagiline for 14 days, then switch to 1mg of Rasagiline for remainder of the study (approximately 10 weeks total).
干预措施: Rasagiline (Drug)
Placebo
0.5mg of placebo for 14 days, then switch to 1mg of placebo for remainder of the study (approximately 10 weeks total)
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in UPSIT score at 10-week visit
时间窗: 10 weeks
次要结局
- Safety: AE incidence(10 weeks)
- Tolerability: Number of subjects (%) who discontinue the study due to AEs(10 weeks)
研究者
Grace Liang
Principal Investigator, Director of Clinical Trials
The Parkinson's Institute