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

Registration Number: EUCTR2007-004890-24-FR

Lead Sponsor: Juvantia Pharma Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 24

Inclusion Criteria

• Male or female patients = 30 and < 80 years of age with an intact oral
mucosa at screening
• Diagnosis of MSA or diagnosis of idiopathic PD
• Hoehn and Yahr stages 1 to 4 during ‘Off’ period
• NOH: reproducible fall in SBP = 20 mmHg and/or a fall in DBP = 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 MSA or PD
• SBP = 200 mmHg or DBP = 120 mmHg after 15 min supine rest in quiet
environment
• Clinically significant abnormalities of ECG
• Mini-Mental State Examination (MMSE) score < 24
• Intake of prohibited concomitant medication (Appendix C), such as
midodrine, intake of medication associated with vasodilatation or induction of
liver enzymes; neuroleptics; certain drugs known to be substantially
metabolized through the following cytochrome P450 isoenzymes: 1A2, 2B6,
2C19, 2C9, 2D6 and 2E1; or any other drug for the treatment of orthostatic
hypotension (including off-label use), such as non-steroidal antiinflammatory
drugs, beta blockers, somatostatin
• 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;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>;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 Outcome Measures

Name	Time	Method

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