Fipamezole in Neurogenic Orthostatic Hypotension

• Status: Unknown status
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Fipamezole is effective in the treatment of orthostatic hypotension and related symptoms in multiple system atrophy and Parkinson's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Juvantia Pharma Ltd
• Collaborator: Santhera Pharmaceuticals

Criteria

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)

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 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 anti-inflammatory 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