Fipamezole in Neurogenic Orthostatic Hypotension

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 …