NCT01574053ClinicalTrials.gov

Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort

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En resumen

Observacional35.000 participantes buscados183 centros20 países

Categorías

Neurología45%Enfermedades raras y genéticas45%Psiquiatría y salud mental10%

Este registro no se ha confirmado recientemente

El patrocinador confirmó por última vez el estado de este registro en febrero de 2024. Puede que ya no sea exacto.

El registro sigue figurando como En reclutamiento, pero nadie lo ha confirmado en 2 años. Contacte con el centro del estudio antes de hacer planes.

Registrado en 1 registro

ClinicalTrials.govNCT01574053Abrir este registro en ClinicalTrials.govSincronizado hace 2 meses

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2012-04-10; recorded start 2012-07-01
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
Not stated: Whether there is a comparison group is not stated in the registry recordThe record does not describe the study arms
Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (CHDI Foundation, Inc.)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: other.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Masking not stated in the record
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 183 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEGA

A very large study, international in scope: 35,000 participants (target), run at 183 sites, across 20 countries.

How this score is built

Enrolment40/40
35,000 participants (target)
Site count25/25
183 sites
Country count15/15
20 countries
Planned duration10/10
Planned over about 603 months
Sponsor scale2/10
CHDI Foundation, Inc. has led 4 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

The primary objective of Enroll-HD is to develop a comprehensive repository of prospective and systematically collected clinical research data (demography, clinical features, family history, genetic characteristics) and biological specimens (blood) from individuals with manifest HD, unaffected individuals known to carry the HD mutation or at risk of carrying the HD mutation, and control research participants (e.g., spouses, siblings or offspring of HD mutation carriers known not to carry the HD mutation). Enroll-HD is conceived as a broad-based and long-term project to maximize the efficiencies of non-clinical research and participation in clinical research. With more than 150 active clinical sites in 23 countries, Enroll-HD is now the largest HD database available and is accessible to any interested researcher - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

Afecciones

Huntington's Disease

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – Sin máximo
Voluntarios sanos	Sí
Método de muestreo	NON_PROBABILITY_SAMPLE

Población del estudio

Patients with HD and their family members are recruited from specialty clinics (Human Genetics, Neurology, Psychiatry) that advise and treat people affected by HD. In addition, in some areas community clinics and neurologists who see HD patients recruit participants for this study. Participants also receive information about the study through websites, clinical practices, support groups, advocacy newsletters, etc. and place a direct request to be considered for participation in the study. Community controls are identified by study site staff (using advertisements, flyers and newsletters) with the support of the Enroll-HD operational staff.

Elegibilidad tal como figura en el registro

Inclusion Criteria: * Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation. * Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation. These two major categories can be further subdivided into six different subgroups of eligible individuals: * Manifest/Motor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD. * Pre-Manifest/-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD. * Genotype Unknown: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has not undergone predictive testing for HD and therefore has an undetermined carrier status. * Genotype Negative: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has undergone predictive testing for HD and is known not to carry the HD expansion mutation. * Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers). * Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies. Participant status will be captured in the study database using 2 variables: 1) Investigator Determined Status: this will be based on clinical signs and symptoms and genotyping performed as part of medical care, and will be updated at every visit; and 2) Research Genotyping Status: this will be based on genotyping conducted as part of Enroll-HD study procedures. Based on research genotyping, participants will be reclassified under this variable from Genotype Unknown to 'Carriers' or 'Controls'. Investigators and participants will be blinded to this reclassification. Exclusion Criteria: * Individuals who do not meet inclusion criteria, * Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation. * For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g. stroke, Parkinson's disease, multiple sclerosis, etc.). Participants under 18 may be eligible to participate (if they have juvenile-onset HD).

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	Observacional
Fase	No indicado en el registro
Asignación	No indicado en el registro
Modelo de intervención	No indicado en el registro
Propósito principal	No indicado en el registro
Enmascaramiento	No indicado en el registro
Inscripción	35.000 participantes buscados

Patrocinador y colaboradores

CHDI Foundation, Inc. Patrocinador

Variables de resultado

Variable de resultado principal
Motor Assessments: Unified Huntington's Disease Rating Scale (UHDRS) 99 Motor, UHDRS '99 Diagnostic Confidence Level
The motor section of the UHDRS assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. UHDRS 99 Motor, UHDRS Diagnostic Confidence Level.
Plazo through study completion, an average of 1 year
Variable de resultado principal
Functional Assessments: UHDRS '99 Total Functional Capacity, UHDRS '99 Functional Assessment Scale, UHDRS '99 Independence Scale
The Total Functional Capacity, Functional Assessment and Independence Subscales of the UHDRS '99 will be used to assess participants' functional status. The Total Functional Capacity scale has established psychometric properties including inter-rater reliability and validity, based on radiographic measures of disease progression.
Plazo through study completion, an average of 1 year
Variable de resultado principal
Problem Behaviors Assessment-Short (PBA-s)
The Problem Behavioral Assessment Short Version (PBA-s) will be used to perform behavioral assessments. This instrument measures frequency and severity of symptoms related to altered affect, thought content and coping styles.
Plazo through study completion, an average of 1 year
Variable de resultado principal
Cognitive Assessments: Symbol Digit Modality Test; Stroop Color Naming; Stroop Word Reading; Categorical Verbal Fluency
Cognition will be assessed using the Categorical Verbal Fluency Test, Symbol Digit Modality Test and Stroop Color and Word Reading Test. Verbal fluency is a commonly used neuropsychological test which examines the ability to spontaneously produce words orally within a fixed time span. For category fluency, words must be produced according to semantic constraints. The measure of performance used will be the number of correctly generated words within 60 seconds.
Plazo through study completion, an average of 1 year

Fechas

Fechas
Fecha de inicio	1 de julio de 2012 (real)
Finalización principal	1 de enero de 2062 (estimada)
Finalización	1 de enero de 2062 (estimada)
Primera publicación	10 de abril de 2012 (estimada)
Última actualización	28 de febrero de 2024
Resultados publicados	No indicado en el registro
Estado verificado por última vez	febrero de 2024

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

160 centros están en reclutamiento

Argentina

Argentina
Centro	Ciudad	Estado o región	Estado
Instituto de Neurociencias Buenos Aires (INEBA)	Buenos Aires		En reclutamiento

Australia

Australia
Centro	Ciudad	Estado o región	Estado
Monash University	Melbourne	Victoria	En reclutamiento
University of Melbourne, Royal Melbourne Hospital	Parkville		En reclutamiento
The Neurosciences Unit - North Metropolitan Hospital	Perth	Western Australia	En reclutamiento
Westmead Hospital	Westmead	New South Wales	En reclutamiento

Austria

Austria
Centro	Ciudad	Estado o región	Estado
Universitatsklinik Innsbruck	Innsbruck		En reclutamiento

Belgium

Belgium
Centro	Ciudad	Estado o región	Estado
Bruxelles - Erasme	Brussels		En reclutamiento
Institut de Pathologie et de Génétique (IPG)	Charleroi		En reclutamiento
University Hospitals Leuven	Leuven	Vlaams-Brabant	En reclutamiento
Hôpital du Beau Vallon ASBL	Saint-Servais		En reclutamiento

Canada

Canada
Centro	Ciudad	Estado o región	Estado
University of Calgary, Movement Disorders Program	Calgary	Alberta	En reclutamiento
University of Alberta (Glenrose)	Edmonton	Alberta	Finalizado antes de tiempo
University of Alberta Hospital in Edmonton	Edmonton	Alberta	En reclutamiento
Nova Scotia Health Authority	Halifax	Nova Scotia	En reclutamiento
Centre for Movement Disorders	Markham	Ontario	Finalizado antes de tiempo
CHUM Hospital of Notre Dame	Montreal	Quebec	En reclutamiento
The Ottawa Hospital	Ottawa	Ontario	En reclutamiento
North York General Hospital	Toronto	Ontario	En reclutamiento
University of British Columbia	Vancouver	British Columbia	En reclutamiento

Chile

Chile
Centro	Ciudad	Estado o región	Estado
CETRAM	Santiago		En reclutamiento

Colombia

Colombia
Centro	Ciudad	Estado o región	Estado
Servicios Médicos MS, Clínica de Marly	Bogotá	Cundinamarca	En reclutamiento
Universidad de Antioquia, Grupo de Neurociencias	Medellín	Antioquia	En reclutamiento

Denmark

Denmark
Centro	Ciudad	Estado
University Hospital of Aarhus	Aarhus	En reclutamiento
University Hospital of Copenhagen	Copenhagen	En reclutamiento
University Hospital of Odense	Odense	En reclutamiento

France

France
Centro	Ciudad	Estado o región	Estado
CHU Amiens-Picardie	Amiens		En reclutamiento
CHU Angers, Centre de Référence Maladies Neurogénétiques	Angers		En reclutamiento
Bordeaux - Huntington Disease competencies center	Bordeaux		En reclutamiento
CHU Gabriel-Montpied	Clermont-Ferrand		En reclutamiento
Hôpital Henri Mondor, Centre d'Investigation Clinique	Créteil		En reclutamiento
Lille-Amiens - Huntington Disease Constituent site	Lille		En reclutamiento
Hôpital La Timone	Marseille		En reclutamiento
CHU Montpellier	Montpellier		En reclutamiento
Institut du Cerveau et de la Moelle Epinière	Paris		En reclutamiento
Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre-Service de Neurologie	Strasbourg	Alsace Lorraine	En reclutamiento
Hôpital Purpan, Centre d'Investigation Clinique	Toulouse		En reclutamiento

Germany

Germany
Centro	Ciudad	Estado
University Hospital Aachen	Aachen	En reclutamiento
University of Berlin	Berlin	En reclutamiento
St. Josef und St. Elisabeth Hospital	Bochum	En reclutamiento
University Hospital Carl Gustav Carus Dresden	Dresden	En reclutamiento
University Hospital Erlangen	Erlangen	En reclutamiento
University Medical Center Freiburg	Freiburg im Breisgau	En reclutamiento
Paracelsus Elena Klinik Kassel	Kassel	En reclutamiento
University Hospital Schleswig-Holstein	Lübeck	En reclutamiento
University Hospital Giessen and Marburg	Marburg	Finalizado antes de tiempo
Technical University of Munich	Munich	En reclutamiento
George-Huntington-Institut GmbH	Münster	En reclutamiento
kbo-Isar-Amper-Klinikum Taufkirchen (Vils)	Taufkirchen	En reclutamiento
University Hopsital of Ulm	Ulm	En reclutamiento
University Hospital of Wuerzburg	Würzburg	En reclutamiento

En el registro figuran 133 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT01574053