Status:
UNKNOWN
Fipamezole in Neurogenic Orthostatic Hypotension
Lead Sponsor:
Juvantia Pharma Ltd
Collaborating Sponsors:
Santhera Pharmaceuticals
Conditions:
Symptomatic Neurogenic Orthostatic Hypotension (NOH)
Parkinson's Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief 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.
Detailed Description
This study will be an exploratory, proof of concept, randomised, placebo-controlled, double-blind, multiple crossover study, with an open-label active run-in phase, in patients with multiple system at...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00758849
Start Date
September 1 2008
End Date
May 1 2009
Last Update
October 1 2008
Active Locations (4)
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1
Hôpital du Haut Lévêque, CHU de Bordeaux
Bordeaux, France, 33604
2
Hôpital de la Cavale Blanche, CHU Brest
Brest, France, 29609
3
Hôpital Purpan CIC du CHU de Toulouse
Toulouse, France, 31059
4
Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa
Lisbon, Portugal, 1649-028