Foehn
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
Sponsor study identifier
interventional
24
2 countries
4
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
September 24, 2008
Actual (reported)September 25, 2008
Actual (reported)May 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To compare the efficacy of fipamezole with that of placebo on orthostatic hypotension as assessed by blood pressure response to orthostatism.
28 days
To compare the efficacy of fipamezole with that of placebo on heart rate (HR) response to orthostatism.
28 days
To compare the efficacy of fipamezole with that of placebo on clinical symptoms.
28 days
One placebo tablet administered tid for 12 days in each of the three crossover treatment blocks, each block separated by 2-days placebo washout
One 30-mg tablet of Fipamezole tid from day 1 to 3; one 60-mg tablet of Fipamezole tid from Day 4 to 6; and one 90-mg tablet of Fipamezole tid from Day 7 to 12 in each of the three crossover treatment blocks, each block separated by 2-days placebo washout
Hôpital du Haut Lévêque, CHU de Bordeaux
Bordeaux, 33604, France
Hôpital de la Cavale Blanche, CHU Brest
Brest, 29609, France
Olivier Rascol, MD
Hôpital Purpan CIC du CHU de Toulouse
First Submitted
September 24, 2008
First Posted
September 25, 2008
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Estimated (date passed)Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease
To explore the relationship between plasma levels of fipamezole and measures of efficacy and safety (pharmacokinetics).
28 days
To assess safety and tolerability of fipamezole.
28 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Hôpital Purpan CIC du CHU de Toulouse
Toulouse, 31059, France
Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa
Lisbon, 1649-028, Portugal
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 1, 2008
Record last verified: 2008-09
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Source: ClinicalTrials.gov.
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