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Sponsors and Collaborators: |
Juvantia Pharma Ltd Santhera Pharmaceuticals |
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Information provided by: | Juvantia Pharma Ltd |
ClinicalTrials.gov Identifier: | NCT00758849 |
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.
Condition | Intervention | Phase |
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Symptomatic Neurogenic Orthostatic Hypotension (NOH) Parkinson's Disease Multiple System Atrophy |
Drug: Placebo Drug: Fipamezole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
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 With Multiple System Atrophy or Parkinson's Disease |
Estimated Enrollment: | 24 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: Placebo
One placebo tablet administered tid for 12 days in each of the three crossover treatment blocks, each block separated by 2-days placebo washout
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2: Active Comparator |
Drug: Fipamezole
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
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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 being investigated for potential use as an adjunctive therapy for PD. Adrenergic alpha-2 receptors inhibit noradrenaline and some other neurotransmitter release from nerve terminals in a tonic manner, and therefore antagonism of this receptor leads in enhanced neurotransmitter release. Alpha-2 receptors are located widely in the body, both in the central nervous system (CNS) and periphery. Pharmacological studies have suggested that either central or peripheral autonomic nervous system is involved in autonomic failure and orthostatic hypotension in MSA and in PD.
Neurogenic orthostatic hypotension in these diseases results from decreased delivery of the sympathetic neurotransmitter noradrenaline (or hormonal adrenaline) to vascular adrenergic receptors, either because of blunted CNS control or impaired function of postganglionic sympathetic neurons. Fipamezole is expected to increase noradrenergic (or adrenergic) turnover in specific areas of the brain or in the periphery in MSA and PD and alleviate symptoms related to fall in BP during orthostatism.
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Laurence Negre-Pages | 33 5 61 25 34 58 | laurence.negres-pages@easyconnect.fr |
France | |
Hôpital Purpan CIC du CHU de Toulouse | |
Toulouse, France, 31059 | |
Hôpital du Haut Lévêque, CHU de Bordeaux | |
Bordeaux, France, 33604 | |
Hôpital de la Cavale Blanche, CHU Brest | |
Brest, France, 29609 | |
Portugal | |
Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa | |
Lisbon, Portugal, 1649-028 |
Principal Investigator: | Olivier Rascol, MD | Hôpital Purpan CIC du CHU de Toulouse |
Responsible Party: | Santhera Pharmaceuticals ( Juha M. Savola, Director Clinical Development ) |
Study ID Numbers: | SNT-II-005 |
Study First Received: | September 24, 2008 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00758849 History of Changes |
Health Authority: | United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Portugal: National Pharmacy and Medicines Institute |
NOH Orthostatic hypotension PAF MSA Shy-Drager syndrome Olivopontocerebellar atrophy |
Striatonigral degeneration Autonomic Failure Parkinson Fipamezole JP-1730 |
Pathological Conditions, Anatomical Hypotension Shy-Drager Syndrome Hypotension, Orthostatic Ganglion Cysts Basal Ganglia Diseases Vascular Diseases Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Multiple System Atrophy Parkinson Disease Movement Disorders Postural Hypotension Atrophy Parkinsonian Disorders |
Pathological Conditions, Anatomical Hypotension Hypotension, Orthostatic Basal Ganglia Diseases Nervous System Diseases Vascular Diseases Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Multiple System Atrophy Parkinson Disease Movement Disorders Atrophy Cardiovascular Diseases Parkinsonian Disorders |