Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in orthostatic diastolic blood pressure
研究概览
简要总结
This study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension.
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
- 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
- •The presence of OH (fall in systolic BP >=30 mm Hg) is required for this study.
- •Autonomic testing and clinical evaluation demonstrates OH to be of neurogenic etiology.
排除标准
- •Pregnant or lactating females.
- •Chronic illnesses or the presence of other conditions that potentially involve the CNS or affect autonomic testing. These include congestive heart failure, recent (<6 months) myocardial infarct, severe anemia, diabetes mellitus, alcoholism, malignant neoplasms, amyloidosis, hypothyroidism, sympathectomy, cerebrovascular accidents, and neurotoxins or neuroactive drug exposure.
- •Orthopedic problems or cardiopulmonary disease, sufficient to compromise mobility and activity of daily living.
- •Any known concurrent infection or severe liver or kidney disease.
- •Medications that could affect autonomic function are suspended prior to autonomic testing. Therapy with midodrine, alpha and beta adrenergic antagonists, or other medications that affect autonomic function will be withdrawn 48 hours prior to autonomic evaluations. Fludrocortisone doses up to 0.2 mg per day will be permitted. Stable doses of antidepressants (tricyclics, SSRIs, SNRIs) will also be permitted. The 48h medication withdrawal is reviewed on a case by case basis - if felt unsafe by the investigators, the withdrawal period may be shortened. This will be documented in the study documents.
- •Occasional use of a neuroleptic as an anti-emetic in the past is allowed, but none can have been used within 3 weeks prior to this study.
- •Use of methylphenidate, cinnarizine, reserpine, amphetamine, atypical antipsychotics such as risperidone, olanzapine, and quetiapine or a MAO-A inhibitor within 3 weeks prior to this study.
- •Dementia (DSM-IV criteria - Amer. Psych. Assoc., 1994). The score on the Mini-Mental State Examination must be >
- •History of stroke (diagnosed on clinical grounds as an acute deterioration of neurological function typical of a stroke; confirmatory CT or MRI evidence of stroke will be useful but not necessary).
- •History of electroconvulsive therapy.
- •History of brain surgery for Parkinson's disease.
研究组 & 干预措施
Placebo, Then Pyridostigmine
participants first receive placebo by mouth 3 times a day, for treatment day 1. Then participants receive pyridostigmine by mouth 3 times a day for treatment day 2.
干预措施: Pyridostigmine (Drug)
Pyridostigmine, Then Placebo
participants first receive pyridostigmine by mouth 3 times a day, for treatment day 1. Then participants receive placebo by mouth 3 times a day for treatment day 2.
干预措施: Pyridostigmine (Drug)
Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine
participants first receive placebo by mouth 3 times a day, for treatment day 3. Then participants receive Droxidopa by mouth 3 times a day for treatment day 4.
干预措施: Droxidopa (Drug)
Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine
participants first receive placebo by mouth 3 times a day, for treatment day 3. Then participants receive Droxidopa by mouth 3 times a day for treatment day 4.
干预措施: Pyridostigmine (Drug)
Droxidopa and Pyridostigmine, Then Droxidopa and Placebo
participants first receive Droxidopa by mouth 3 times a day, for treatment day 3. Then participants receive Placebo by mouth 3 times a day for treatment day 4.
干预措施: Droxidopa (Drug)
Droxidopa and Pyridostigmine, Then Droxidopa and Placebo
participants first receive Droxidopa by mouth 3 times a day, for treatment day 3. Then participants receive Placebo by mouth 3 times a day for treatment day 4.
干预措施: Pyridostigmine (Drug)
Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine
participants first receive placebo by mouth 3 times a day, for treatment day 3. Then participants receive Droxidopa by mouth 3 times a day for treatment day 4.
干预措施: Placebo (Other)
Placebo, Then Pyridostigmine
participants first receive placebo by mouth 3 times a day, for treatment day 1. Then participants receive pyridostigmine by mouth 3 times a day for treatment day 2.
干预措施: Placebo (Other)
Pyridostigmine, Then Placebo
participants first receive pyridostigmine by mouth 3 times a day, for treatment day 1. Then participants receive placebo by mouth 3 times a day for treatment day 2.
干预措施: Placebo (Other)
Droxidopa and Pyridostigmine, Then Droxidopa and Placebo
participants first receive Droxidopa by mouth 3 times a day, for treatment day 3. Then participants receive Placebo by mouth 3 times a day for treatment day 4.
干预措施: Placebo (Other)
结局指标
主要结局
Change in orthostatic diastolic blood pressure
时间窗: 1 hour after medication administration, 2 hours after medication administration
diastolic blood pressure measured upon standing reported in mm/Hg
次要结局
- Change in absolute supine diastolic blood pressure(1 hour after medication administration, 2 hours after medication administration)
- Change in supine norepinephrine levels(1 hour after medication administration, 2 hours after medication administration)
- Change in orthostatic symptoms(1 hour after medication administration, 2 hours after medication administration)
- Change in orthostatic systolic blood pressure(1 hour after medication administration, 2 hours after medication administration)
- Change in absolute supine systolic blood pressure(1 hour after medication administration, 2 hours after medication administration)
研究者
Wolfgang Singer, MD
Principal Investigator
Mayo Clinic