Clinical Trial: Fipamezole in Neurogenic Orthostatic Hypotension

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients W

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 Summary:

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 atrophy (MSA) or Parkinson's disease (PD) who can concomitantly be treated with fludrocortisone and antiparkinsonian medication. Three sites in France and one site in Portugal will participate in this study.

During the open-label active run-in phase, a tolerated dose-escalation regimen (either escalating from 30 to 90 or 60 mg tid, or no escalation but fixed dose of 30 mg tid) will be established for each patient. Once the tolerated treatment regimen has been established, patients will then be randomised to the double-blind crossover treatment. Fipamezole and matched placebo tablets are compared in 3 crossover blocks, each block consisting of a total of 28 days: 12 days fipamezole and 12 days placebo in random order, separated by two days of washout. The patients will be randomly assigned to one of the two possible treatment sequences (fipamezole first followed by placebo or placebo first followed by fipamezole).

For efficacy assessments, the patient blood pressure and heart rate is assessed repeatedly when laying still or standing. Impact of orthostatic hypotension on clinical symptoms is assessed with a subjective scale and questionnaire. To explore potential positive or negative impact of fipamezole on disease characteristics, the MSA and PD patients are assessed with UMSARS and UPDRS scales, respectively. Finally, the study includes investigator and patients assessments of CGI-I and PGI-I scales for clinical condition in general.

Fipamezole

Fipamezole is a new antagonist of the pre-synaptic adrenergic alpha-2 receptors and is
Sponsor: Juvantia Pharma Ltd

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Juvantia Pharma Ltd

Dates:
Date Received: September 24, 2008
Date Started: September 2008
Date Completion: May 2009
Last Updated: September 30, 2008
Last Verified: September 2008