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El ensayo clínico NCT05966038 para ELA, PLS, EMN (Enfermedad de la motoneurona), Enfermedad de Kennedy, PMA - Progressive Muscular Atrophy, PBP - Progressive Bulbar Palsy está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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ALS/MND Natural History Study Data Repository 5000 Basado en biomarcadores
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT05966038 es un estudio observacional para ELA, PLS, EMN (Enfermedad de la motoneurona), Enfermedad de Kennedy, PMA - Progressive Muscular Atrophy, PBP - Progressive Bulbar Palsy. Su estado actual es: reclutando. El estudio se inició el 1 de abril de 2015, con el objetivo de reclutar a 5000 participantes. Dirigido por Massachusetts General Hospital, se espera que finalice el 31 de diciembre de 2030. Los datos se actualizaron por última vez en ClinicalTrials.gov el 14 de noviembre de 2025.
Resumen
This is a data repository for multi-site multi-protocol clinic-based Natural History Study of ALS and Other Motor Neuron Disorders (MND).
All people living with ALS or other MNDs who attend clinics at the Study hospitals (sites) are offered to participate in the Study.
The Sites collect so-called Baseline information including demographics, disease history and diagnosis, family history, etc. At each visit, the Site...
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Most people with ALS or MND who are seen clinically by the PI or PI designees at participating sites will be recruited into this study. This well-established framework provides an opportunity to offer to a large proportion of people with ALS/MND a chance to participate in a clinical research project.
Upon obtaining consent, the following is done:
People with ALS/MND are assigned a Neurological Global Unique Identif...
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ALS/MND Natural History Study Data Repository
Condiciones médicas
ELAPLSEMN (Enfermedad de la motoneurona)Enfermedad de KennedyPMA - Progressive Muscular AtrophyPBP - Progressive Bulbar PalsyOtros ID del estudio
- 2013P001670
- 5U01FD008125-02 (Subvención/contrato FDA (EE. UU.))
- 2022A011556 (Otra financiación) (Biogen, Inc.)
- 2022A018800 (Otra financiación) (Mitsubishi Tanabe Pharma America)
Número del NCT
Inicio del estudio (real)
2015-04-01
Última actualización
2025-11-14
Fecha de finalización (estimada)
2030-12-31
Inscripción (prevista)
5000
Tipo de estudio
Observacional
Estado general
Reclutando
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
ALS Functional Rating Scale-Revised (ALSFRS-R) | The ALS Functional Rating Scale revised is a 12-item rating scale that measures the progression of disability in patients with ALS. The ALSFRS-r assesses patients' levels of self-sufficiency in areas of feeding, grooming, ambulation and communication. The higher the score, the earlier in the disease progression.
It consists of 12 questions with a maximum score of 48 points. | Every 3-4 months up to 5 years |
Slow Vital Capacity (SVC) | Slow vital capacity test normalized to age, sex, and height | Every 3-4 months up to 5 years |
Survival | Patient survival or survival equivalent (time to ventilator or feeding tube). Survival equivalent is assessed during routine clinical visits, while mortality event may be reported when becomes known to the treating clinician.. | Every 3-4 months up to 5 years |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Vital Signs | Vital Signs (Weight, BP, HR). Both systolic and diastolic pressure are measured. | Every 3-4 months up to 5 years |
Neurological Examination | Neurological exam that tests for abnormality various areas, from general assessment to coordination and cerebellar function, to sensation and reflexes, to cranial nerves and plantar | Through study completion, annually up to 5 years |
El Escorial Criteria | The El Escorial criteria are diagnostic criteria for ALS. They classify patients into categories of possible, probable, or definite ALS, based on signs of degeneration of upper and lower motor neurons in different body regions. | Through study completion, annually up to 5 years |
Handheld Dynamometry | Handheld Dynamometry for quantitative strength testing of 18 muscles that is a reliable and reproducible measure of decline in ALS | Every 3-4 months up to 5 years |
Grip Strength Testing | Grip Strength Testing | Every 3-4 months up to 5 years |
Rasch Overall ALS Disability Scale (ROADS) | Rasch Overall ALS Disability Scale, the ROADS provides a normed total score on 28 items from 0-146 to capture overall disability level in a linearly-weighted manner, with lower scores indicating disease progression | Every 3-4 months up to 5 years |
5 Times Sit to Stand | 5 Times Sit to Stand Test | Every 3-4 months up to 5 years |
10 Meter Walk Test | 10 Meter Walk Test | Every 3-4 months up to 5 years |
Physical Examination | Physical Examination that includes the following test areas for abnormality and clinical significance: respiratory, cardio, gastrointestinal, genitourinary. and musculoskeletal | Through study completion, annually up to 5 years |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- A clinical diagnosis of El Escorial of suspected, possible, probable, or definite ALS or
- Other motor neuron disorders, including but not limited to Spinal-Bulbar Muscular Atrophy (SBMA, Kennedy's disease), Spinal Muscular Atrophy (SMA), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA), and Progressive Bulbar Palsy (PBP)
- Disease does not meet criteria for any motor neuron disorder
Massachusetts General Hospital- ⚕️Henry ...
Parte responsable del estudio
Alexander Sherman, Investigador principal, Director, Center for Innovation and Bioinformatics, Massachusetts General Hospital
Contactos centrales del estudio
Contacto: Natalia Tarasenko, 1617240346, [email protected]
16 Centros del estudio en 3 países
California
Loma Linda University Health, Loma Linda, California, 92354, United States
Jeffrey Rosenfeld, MD, Investigador principal
Reclutando
Kaiser Permanente, Los Angeles, California, 90027, United States
Chris Greer, Contacto, 323-783-9284, [email protected]
Abel Wu, MD, Investigador principal
Reclutando
Florida
University of Florida, Gainesville, Florida, 32610, United States
Jennifer Steshyn, Contacto, [email protected]
James Wymer, Investigador principal
Reclutando
Illinois
Northwestern University, Chicago, Illinois, 60611, United States
Emma Schmidt, Contacto, 13125034362, [email protected]
Senda Ajroud-Driss, Investigador principal
Reclutando
Massachusetts
Lahey Clinic, Burlington, Massachusetts, 01805, United States
Sorieba Fofanah, Contacto, 781-744-2958, [email protected]
Melo Catia, Contacto, [email protected]
Medhi Ghasemi, MD, Investigador principal
Reclutando
Michigan
Henry Ford Health System, Detroit, Michigan, 48202, United States
Anne Vallis, Contacto, 13139161364, [email protected]
Ximena Arcila Londono, Investigador principal
Reclutando
Minnesota
University of Minnesota, Minneapolis, Minnesota, 55455, United States
Valerie Ferment, Contacto, 16123011535, [email protected]
David Walk, Investigador principal
Reclutando
Missouri
Saint Louis University, St Louis, Missouri, 63104, United States
Katie Forsman, Contacto, [email protected]
Ghazala Hayat, Investigador principal
Reclutando
Oregon
Providence ALS Clinic, Portland, Oregon, 97213, United States
Tyler Regan, Contacto, 15032152333, [email protected]
Nicholas Olney, Investigador principal
Reclutando
Pennsylvania
Temple University Lewis Katz School of Medicine, Philadelphia, Pennsylvania, 19140, United States
John Furey, Contacto, 12676940573, [email protected]
Terry Heiman-Patterson, Investigador principal
Reclutando
University of Pittsburgh, Pittsburgh, Pennsylvania, 15360, United States
Helen Ismail, Contacto, 4128642873, [email protected]
Tawfiq Al-lahham, MD, Investigador principal
Reclutando
Virginia
Virginia Commonwealth University, Richmond, Virginia, 22908, United States
Demetrius Carter, Contacto, [email protected]
Kelly Gwathmey, Investigador principal
Reclutando
Hadassah Medical Organization, Jerusalem, 9112001, Israel
Michal Zabari, Contacto, [email protected]
Marc Gotkine, MD, Investigador principal
Reclutando
Tel Aviv Medical Center, Tel Aviv, 64239, Israel
Beatrice Abramovich, Contacto, [email protected]
Vivian Drori, MD, Investigador principal
Reclutando
Centro Clinico NEMO Milano, Milan, 20162, Italy
Monica Montuori, Contacto, [email protected]
Federica Cerri, Investigador principal
Reclutando
Istituti Clinici Scientifici Maugeri SpA, Milan, 20138, Italy
Camilla Garrè, Contacto, [email protected]
Christian Lunetta, MD, Investigador principal
Rachele Piras, MD, Subinvestigador
Reclutando