A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEH

Juvantia Pharma Ltd0 个研究点目标入组 24 人开始时间: 2008年6月25日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Male or female patients = 30 years of age with an intact oral mucosa
•- Diagnosis of multiple system atrophy or diagnosis of idiopatic Parkinson's disease
•- Hoehn and Yahr stages 1 to 4 during ‘Off’ period
•- Neurogenic orthostatic hypotension: reproducible fall in systolic blood pressure =20 mmHg and/or a fall in diastolic blood pressure =10 mmHg between 15 min of supine rest and 3 min of standing (or until symptomatic from hypotension after <3 min of standing)
•- For patient taking antiparkinsonian medication: stable daily dosing for at least 1 month
•- For patient taking fludrocortisone: stable dose for at least 2 months
•- Demonstrated ability to comprehend, give informed consent and comply with study procedures (BP self-monitoring, completion of patient diary and self-assessment rating scales)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Other clinically significant conditions apart from those typically associated with multiple system atrophy or Parkinson's disease
•- Systolic blood pressure =200 mmHg or diastolic blood pressure =120 mmHg after 15 min supine rest in quiet environment
•- Clinically significant abnormalities of ECG
•- Mini-Mental State Examination score < 24
•- Intake of prohibited concomitant medication, such as midodrine, intake of medication associated with vasodilatation or induction of liver enzymes; neuroleptics; or certain drugs known to be substantially metabolized through the following cytochrome P450 isoenzymes: 1A2, 2B6, 2C19, 2C9, 2D6 and 2E1
•- Use of St. John’s Wort or Ginkgo Biloba within 48 h prior to inclusion and during the course of the study
•- Intake of an investigational drug within 30 days prior to screening

发起方

Juvantia Pharma Ltd