E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure |
Hipotensión ortostática neurogénica sintomática en sujetos con fallo autonómico primario |
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E.1.1.1 | Medical condition in easily understood language |
symptomatic neurogenic Orthostatic Hypotension (snOH) in people with Parkinson's disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) |
Hipotensión ortostática neurogénica sintomática (HOns) en sujetos con la enfermedad de Parkinson (EP), la atrofia multisistémica (AMS) o fallo anatómico puro (FAP) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to evaluate the long-term safety of TD-9855 over a 182-week period. |
Evaluar la seguridad a largo plazo de TD-9855 en un periodo de 182 semanas. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Completion of Study 0170 and, in the opinion of the Investigator, would benefit from long-term treatment with TD-9855. 2. The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject’s current therapeutic regimen). 3. The subject must be willing to continue on treatment and must continue to meet all the inclusion criteria for the preceding study (Study 0170) except, a score of ≥4 in OHSA#1. |
1. El sujeto debe haber finalizado el estudio 0170 y, en opinión del investigador, puede beneficiarse del tratamiento a largo plazo con TD-9855. 2. El sujeto debe ser capaz de entender la naturaleza del estudio y proporcionar su consentimiento informado por escrito antes de la realización de cualquier procedimiento del estudio (incluido cualquier cambio que se produzca en la pauta terapéutica actual del sujeto). 3. El sujeto debe estar dispuesto a continuar con el tratamiento y debe seguir cumpliendo con todos los criterios de inclusión del estudio anterior (estudio 0170), excepto una puntuación >4 en la OHSA#1. |
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E.4 | Principal exclusion criteria |
1. Subjects may not be enrolled in another clinical trial, with the exception of purely observational studies, which are allowed. 2. Psychiatric, neurological, or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study. 3. Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant. 4. Hypersensitivity to TD-9855 or the formulation excipients. |
1. Los sujetos no se pueden inscribir en otro ensayo clínico, a excepción de los estudios puramente observacionales, que están permitidos. 2. Padecer trastornos del comportamiento, neurológicos o psiquiátricos que pueden interferir en la capacidad de los sujetos para otorgar su consentimiento informado o en la realización del estudio. 3. Cuestiones médicas, analíticas o quirúrgicas consideradas por el investigador como clínicamente significativas. 4. Hipersensibilidad a TD-9855 o los excipientes de su formulación. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary safety and tolerability endpoints include: • Physical examination • Neurological examination • Vital signs • Resting ECGs • Clinical laboratory tests including biochemistry, hematology, and urinalysis. • Concomitant medication • AEs • Subject compliance to study treatment • Incidence of falls • Columbia Suicide Severity Rating Scale (C-SSRS) |
Los criterios de valoración principales de seguridad y tolerabilidad incluyen: • Exploración física • Exploración neurológica • Constantes vitales • ECG en reposo • Análisis clínicos, que incluyen bioquímica, hematología y análisis de orina. • Medicación concomitante • AA • Cumplimiento por parte del sujeto del tratamiento del estudio • Incidencia de caídas • Escala Columbia para evaluar el riesgo de suicidio (Columbia Suicide Severity Rating Scale, C-SSRS). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
• Physical examination evaluated at visits 1,4, 6 • Neurological examination evaluated at visits 1,4, 6 • Vital signs evaluated at visits 1, 2, 3, 4, 5, 6 • Resting ECGs evaluated at visits 1, 4, 6 • Clinical laboratory tests including biochemistry, hematology, and urinalysis evaluated at visits 1, 4 and 6 • Concomitant medication evaluated at all visits and at telephone contacts • Subject compliance to study treatment evaluated at visits 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 • Incidence of falls evaluated at visits 1, 2, 3, 4, 5 and 6 • Columbia Suicide Severity Rating Scale (C-SSRS) evaluated at visits 1, 2, 3, 4, 5 and 6 |
• Exploración física evaluada en las visitas 1, 4, 6 • Exploración neurológica evaluada en las visitas 1, 4, 6 • Constantes vitales evaluadas en las visitas 1, 2, 3, 4, 5, 6 • ECG en reposo evaluado en las visitas 1, 4, 6 • Análisis clínicos, que incluyen bioquímica, hematología y análisis de orina evaluados en las visitas 1, 4, 6 • Medicación concomitante evaluada en todas las visitas y contactos telefónicos • Cumplimiento por parte del sujeto del tratamiento del estudio evaluado durante las visitas 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 • Incidencia de caídas evaluadas durante las visitas 1, 2, 3, 4, 5 y 6 • Escala Columbia para evaluar el riesgo de suicidio (Columbia Suicide Severity Rating Scale, C-SSRS) evaluada en la visitas 1, 2, 3, 4, 5 y 6 |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Austria |
Bulgaria |
Canada |
Czech Republic |
Denmark |
Estonia |
France |
Germany |
Hungary |
Ireland |
Israel |
Italy |
New Zealand |
Poland |
Portugal |
Russian Federation |
Spain |
Ukraine |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
ültima visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 13 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 13 |