Clinical trial • Phase IV • Neurology
FLUDROCORTISONE ACETATE for Neurogenic orthostatic hypotension
Phase IV trial of FLUDROCORTISONE ACETATE for Neurogenic orthostatic hypotension.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Neurogenic orthostatic hypotension
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule|Other
Key dates
- Initial CTIS Submission Date
- 01-10-2024
- First CTIS Authorization Date
- 29-10-2024
Trial design
Cellulose microcristalline 50 microgrammes (placebo) — product listed as placebo; no dosing schedule specified-controlled Phase IV trial in France.
- Comparator
- Cellulose microcristalline 50 microgrammes (placebo) — product listed as placebo; no dosing schedule specified
- Target Sample Size
- 90
- Trial Duration For Participant
- 28
Eligibility
Recruits 90 Vulnerable population selection indicated (isVulnerablePopulationSelected: true). No specific information on consent/assent procedures or additional protections for vulnerable participants is provided in the available record..
- Pregnancy Exclusion
- Pregnant or breastfeeding patients
- Vulnerable Population
- Vulnerable population selection indicated (isVulnerablePopulationSelected: true). No specific information on consent/assent procedures or additional protections for vulnerable participants is provided in the available record.
Inclusion criteria
- {"criterion_text":"- Age >18 years\n- Orthostatic hypotension (blodo pressure decrease >20 and/or 10mmHg on systolic and diastolic values within 3 minutes after standup, and symptomatic according to the Orthostatic Hypotension Questionnaire OHQ: score different than 0 in at least 1 of the 6 items\n- Patients suffering from a neurologic disease (Parkinson disease, multisystemic atrophy, Lewy bodies dementia, isolated progressive dysautonomia) or metabolic disease (diabetes, renal failure) known to be linked with an autonomous nervous system dysfunction and with NOH\n- Persisting and symptomatic NOH despite the use of non-medicinal measures (lower limbs contention) and medicinal products (midodrine)"}
Exclusion criteria
- {"criterion_text":"- Age <18 years\n- Hypersensitivity to FLU or to one of its excipients\n- Medical history of documented cardiac failure\n- Medical history of left ventricular systolic dysfunction\n- Non-compensated hypokalaemia\n- Nocturnal or supine hypertension\n- Pregnant or breastfeeding patients"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Efficacy on the systolic and diastolic BP decrease when moving from supine and stand-up position","definition_or_measurement_approach":"Change in systolic and diastolic blood pressure from supine to standing; primary objective specifies measurement after 5 minutes of active orthostatism (4-week treatment effect on BP decrease after 5 minutes of active orthostatism)."}
Secondary endpoints
- {"endpoint_text":"- Evaluation of the symptoms related to NOH through the OHQ scale\n- Evaluation of the quality of life through the SF36 scale\n- Collection of clinical adverse events, biological and blood pressure anomalies","definition_or_measurement_approach":"Symptoms: assessed using the Orthostatic Hypotension Questionnaire (OHQ) scale; Quality of life: assessed using the SF-36 scale; Safety: collection/reporting of clinical adverse events, biological abnormalities and blood pressure anomalies (AE reporting, laboratory tests and BP monitoring as per protocol)."}
Recruitment
- Planned Sample Size
- 90
- Recruitment Window Months
- 77
- Consent Approach
- Adults (age >18) provide informed consent. A subject information and informed consent form document is listed in the record, but details (assent procedures, age-specific documents, available languages) are not provided in the available data.
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 90
France
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 29-10-2024
- Processing Time Days
- 15
- Number Of Sites
- 10
- Number Of Participants
- 90
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Endocrinologie
- Principal Investigator Name
- Emmanuelle VIDAL-PETIOT
- Principal Investigator Email
- emmanuelle.vidal-petiot@aphp.fr
- Contact Person Name
- Emmanuelle VIDAL-PETIOT
- Contact Person Email
- emmanuelle.vidal-petiot@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Gériatrie
- Principal Investigator Name
- Anne-Sophie BOUREAU
- Principal Investigator Email
- annesophie.boureau@chu-nantes.fr
- Contact Person Name
- Anne-Sophie BOUREAU
- Contact Person Email
- annesophie.boureau@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Neurologie
- Principal Investigator Name
- Anne PAVY-LE TRAON
- Principal Investigator Email
- pavy-letraon.a@chu-toulouse.fr
- Contact Person Name
- Anne PAVY-LE TRAON
- Contact Person Email
- pavy-letraon.a@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Médecine Gériatrique Aigue
- Principal Investigator Name
- Cédric ANNWEILER
- Principal Investigator Email
- ceAnnweiler@chu-angers.fr
- Contact Person Name
- Cédric ANNWEILER
- Contact Person Email
- ceAnnweiler@chu-angers.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Neurologie
- Principal Investigator Name
- Jing XIE
- Principal Investigator Email
- jing.xie@chu-lyon.fr
- Contact Person Name
- Jing XIE
- Contact Person Email
- jing.xie@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Unité de Médecine interne et soins aigus gériatriques
- Principal Investigator Name
- Hubert BLAIN
- Principal Investigator Email
- h-blain@chumontpellier.fr
- Contact Person Name
- Hubert BLAIN
- Contact Person Email
- h-blain@chumontpellier.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Gériatrie
- Principal Investigator Name
- Olivier HANON
- Principal Investigator Email
- olivier.hanon@aphp.fr
- Contact Person Name
- Olivier HANON
- Contact Person Email
- olivier.hanon@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Médecine Polyvalente Gériatrique et SSR
- Principal Investigator Name
- Anne-Sophie BOUREAU
- Principal Investigator Email
- annesophie.boureau@chu-nantes.fr
- Contact Person Name
- Anne-Sophie BOUREAU
- Contact Person Email
- annesophie.boureau@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Médecine Gériatrique Aigue
- Principal Investigator Name
- Anne-Sophie BOUREAU
- Principal Investigator Email
- annesophie.boureau@chu-nantes.fr
- Contact Person Name
- Anne-Sophie BOUREAU
- Contact Person Email
- annesophie.boureau@chu-nantes.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Gérontologie clinique
- Principal Investigator Name
- Achille TCHALLA
- Principal Investigator Email
- Achille.Tchalla@chu-limoges.fr
- Contact Person Name
- Achille TCHALLA
- Contact Person Email
- Achille.Tchalla@chu-limoges.fr
Sponsor
Primary sponsor
- Full Name
- H.A.C. Pharma
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- FLUCORTAC 50 microgrammes, comprimé sécable
- Active Substance
- FLUDROCORTISONE ACETATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation number 3400939060668)
- Starting Dose
- 50 µg (tablet strength)
- Maximum Dose
- 200 µg/day
- Investigational Product Name
- Cellulose microcristalline 50 microgrammes
- Modality
- Other
- Starting Dose
- 50 µg (product nominal strength indicated)
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