Fipamezole in Neurogenic Orthostatic Hypotension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00758849
• Date of registration: 24/09/2008
• Prospective Registration: No
• Primary sponsor: Juvantia Pharma Ltd
• Public title: Fipamezole in Neurogenic Orthostatic Hypotension Foehn
• Scientific title: 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
• Date of first enrolment: September 2008
• Target sample size: 24
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT00758849
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France, Portugal

Contacts

• Name: Olivier Rascol, MD
• Affiliation: Hôpital Purpan CIC du CHU de Toulouse

• Name: Laurence Negre-Pages

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple System Atrophy

Parkinson's Disease

Symptomatic Neurogenic Orthostatic Hypotension (NOH)

Intervention(s)

Drug: Placebo

Drug: Fipamezole

Primary Outcome(s)

To compare the efficacy of fipamezole with that of placebo on orthostatic hypotension as assessed by blood pressure response to orthostatism. [Time Frame: 28 days]

Secondary Outcome(s)

To assess safety and tolerability of fipamezole. [Time Frame: 28 days]

To compare the efficacy of fipamezole with that of placebo on clinical symptoms. [Time Frame: 28 days]

To explore the relationship between plasma levels of fipamezole and measures of efficacy and safety (pharmacokinetics). [Time Frame: 28 days]

To compare the efficacy of fipamezole with that of placebo on heart rate (HR) response to orthostatism. [Time Frame: 28 days]

Secondary ID(s)

SNT-II-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Santhera Pharmaceuticals