Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease MedDRA version: 9.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's MedDRA version: 9.1 Level: LLT Classification code 10064060 Term: Multiple system atrophy
Conditions
Interventions
Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets
Product Code: JP-1730/F01
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: Fipamezole hydrochloride
CAS Number:
Sponsors
Juvantia Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients = 30 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - To compare the efficacy of fipamezole with that of placebo on clinical symptoms. - To explore the relationship between plasma levels of fipamezole and measures of efficacy and safety (pharmacokinetics). - To assess safety and tolerability of fipamezole. ;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 | — |
Countries
France, Portugal
Outcome results
None listed