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

Conditions: MedDRA version: 9.1Level: LLTClassification code 10064060Term: Multiple system atrophy
eurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease
MedDRA version: 9.1Level: LLTClassification code 10013113Term: Disease Parkinson's

Registration Number: EUCTR2007-004890-24-PT

Lead Sponsor: Juvantia Pharma Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of fipamezole with that of placebo on orthostatic hypotension as assessed by blood pressure (BP) response to orthostatism;Primary end point(s): Difference between fipamezole and placebo in maximal fall (standing versus supine) at 1, 2 or 3 hours post-dose in systolic BP (SBP) in response to orthostatism;Secondary Objective: - To compare the efficacy of fipamezole with that of placebo on heart rate (HR) response to orthostatism<br>- To compare the efficacy of fipamezole with that of placebo on clinical symptoms.<br>- To explore the relationship between plasma levels of fipamezole and measures of efficacy and safety (pharmacokinetics).<br>- To assess safety and tolerability of fipamezole.<br>

Secondary Outcome Measures

Name	Time	Method

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